20170214 diabetes MCharlton · 2020. 7. 28. · Diabetes mellitus is a major cause of morbidity and...

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Topic proposal I understand that this proposal will be retained by the SIGN Programme Lead and be made available on the SIGN website for time period that the proposal is being considered. Only proposals with a completed Declaration of Interests for the principal proposer will be considered 1. What is the problem/need for a guideline/clinical scenario? Diabetes mellitus is a major cause of morbidity and mortality in Scotland and worldwide, with an increasing prevalence. Type 2 diabetes develops gradually and people can have the condition with no symptoms. As a result, many people have undiagnosed type 2 diabetes. The Scottish Diabetes Survey estimated the number of people over 16 years of age with undiagnosed diabetes in Scotland in 2015 at 30,559 or 0.7% of the whole population or just under 10% of all people with diabetes. 1 There is increasing evidence that if prediabetes (impaired glucose tolerance) is treated, the progression to diabetes can be prevented. Modification of adverse lifestyle factors is an important aspect of the management of all types of diabetes. In particular, appropriate management of cardiovascular risk factors such as smoking, physical inactivity and poor diet is important for the prevention of macrovascular disease. Eating healthily is of fundamental importance as part of diabetes healthcare behaviour and has beneficial effects on weight, metabolic control and general well being. Carbohydrate-restricted diets have been reported to be effective for glycemic control in people with type 2 diabetes 2. Burden of the condition Mortality In 2015 10,937 people with diabetes died, accounting for 3.7% of the population with diabetes in Scotland. Incidence For 2015, the crude incidence rate of Type 2 diabetes for all ages was 319 per 100,000 population per year and 17 for Type 1 diabetes. Prevalence In 2015 there were around 284,000 people registered as having diabetes in Scotland. 88.3% (250,881) of all people registered with diabetes had Type 2 diabetes. Prevalence of diabetes ranged from 4.5% to 6.1% across NHS boards. 3. Variations In practice in Scotland In health outcomes in Scotland There continues to be significant variation between different NHS boards in the outcomes achieved. 4. Areas of uncertainty to be covered Key question 1 Should a low carbohydrate/high fat diet be a first step for those diagnosed with Type 2 diabetes before prescription of drugs? Key question 2 1 NHS Scotland. Scottish Diabetes Survey 2015. Scottish Diabetes Survey Monitoring Group. NHS Scotland; 2015. Available from url: http://www.diabetesinscotland.org.uk/Publications/SDS2015.pdf

Transcript of 20170214 diabetes MCharlton · 2020. 7. 28. · Diabetes mellitus is a major cause of morbidity and...

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Topic proposal

I understand that this proposal will be retained by the SIGN Programme Lead and be made available on the SIGN website for time period that the proposal is being considered. Only proposals with a completed Declaration of Interests for the principal proposer will be considered

1. What is the problem/need for a guideline/clinical scenario? Diabetes mellitus is a major cause of morbidity and mortality in Scotland and worldwide, with

an increasing prevalence. Type 2 diabetes develops gradually and people can have the condition with no symptoms. As a result, many people have undiagnosed type 2 diabetes. The Scottish Diabetes Survey estimated the number of people over 16 years of age with undiagnosed diabetes in Scotland in 2015 at 30,559 or 0.7% of the whole population or just under 10% of all people with diabetes.1 There is increasing evidence that if prediabetes (impaired glucose tolerance) is treated, the progression to diabetes can be prevented. Modification of adverse lifestyle factors is an important aspect of the management of all types of diabetes. In particular, appropriate management of cardiovascular risk factors such as smoking, physical inactivity and poor diet is important for the prevention of macrovascular disease. Eating healthily is of fundamental importance as part of diabetes healthcare behaviour and has beneficial effects on weight, metabolic control and general well being. Carbohydrate-restricted diets have been reported to be effective for glycemic control in people with type 2 diabetes

2. Burden of the condition Mortality

In 2015 10,937 people with diabetes died, accounting for 3.7% of the population with diabetes in Scotland. Incidence For 2015, the crude incidence rate of Type 2 diabetes for all ages was 319 per 100,000 population per year and 17 for Type 1 diabetes. Prevalence In 2015 there were around 284,000 people registered as having diabetes in Scotland. 88.3% (250,881) of all people registered with diabetes had Type 2 diabetes. Prevalence of diabetes ranged from 4.5% to 6.1% across NHS boards.

3. Variations In practice in Scotland

In health outcomes in Scotland There continues to be significant variation between different NHS boards in the outcomes achieved.

4. Areas of uncertainty to be covered Key question 1

Should a low carbohydrate/high fat diet be a first step for those diagnosed with Type 2 diabetes before prescription of drugs?

Key question 2

                                                            1 NHS Scotland. Scottish Diabetes Survey 2015. Scottish Diabetes Survey Monitoring Group. NHS Scotland; 2015. Available from url: http://www.diabetesinscotland.org.uk/Publications/SDS2015.pdf 

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Should the guidance on diet be revised to remove references to low fat diets for diabetics?

Key question 3 Should fasting be recommended as a method for resetting control of diabetes with insulin?

Key question 4 Should the current method of testing for diabetes be changed: testing for insulin and glucose levels to facilitate diagnoses of prediabetes and allow early intervention?

5. Areas that will not be covered

Long term management, people with Type 1 diabetes

6. Aspects of the proposed clinical topic that are key areas of concern for patients, carers and/or the organisations that represent them

People are concerned about putting on weight and becoming increasingly less healthy, having to take more and more medication for the wide variety of complaints, such as sleep apnoea, leg ulcers, high blood pressure, kidney failure, swollen feet requiring visits to specialists, organ failures, amputations and ultimately death.

7. Population Included

People with type 2 diabetes Not included People with type 1 diabetes

8. Healthcare setting   Included

Primary, secondary and community care

  Not included n/a

9. Potential Potential to improve current practice

Potential to reduce variation in management of early type 2 diabetes Potential impact on important health outcomes (name measureable indicators) Potential to: reduce Hba1c, lead to weight lose, reduce complications

Potential impact on resources (name measureable indicators) Potential to reduce costs if diabetes is managed early without pharmacological intervention and if complications are reduced.

   

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10. What evidence based guidance is currently available? None

Out-of-date (list) Current (list) SIGN 116: Management of diabetes (2010) http://www.sign.ac.uk/pdf/sign116.pdf NICE NG28 Type 2 diabetes in adults: management (2015) Type 2 diabetes in adults: management | Guidance and guidelines | NICE

11. Relevance to current Scottish Government policies

12. Who is this guidance for?

All healthcare professionals involved in the care of people with diabetes

13. Implementation Links with existing audit programmes

Scottish Diabetes Survey http://www.diabetesinscotland.org.uk/Publications/SDS2015.pdf Existing educational initiatives Diabetes Education Scotland http://www.diabeteseducationscotland.org.uk/ Strategies for monitoring implementation Potential to link with the Scottish Care Information – Diabetes Collaboration (SCI-DC) and the Managed Clinical Networks for diabetes.

14. Primary contact for topic proposal

Martin Charlton

15. Group(s) or institution(s) supporting the proposal

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Declaration of Interests Please complete all sections and if you have nothing to declare please put ‘N/A

Having read the attached SIGN Policy on Declaration of Competing Interests I declare the following competing interests for the previous year, and the following year. I understand that this declaration will be retained by the SIGN Programme Lead and be made available on the SIGN website for time period that the proposal is being considered.

Signature:

Name:

Relationship to SIGN: Topic proposal primary contact

Date:

Date received at SIGN:

Personal Interests Remuneration from employment

Name of Employer and Post held

Nature of Business Self or partner/ relative

Specific?

Details of employment held which may be significant to, or relevant to, or bear upon the work of SIGN

Remuneration from self employment

Name of Business Nature of Business Self or partner/ relative

Specific?

Details of self employment held which may be significant to, or relevant to, or bear upon the work of SIGN

Remuneration as holder of paid office

Nature of Office held

Organisation

Self or partner/ relative

Specific?

Details of office held which may be significant to, or relevant to, or bear upon the work of SIGN

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Remuneration as a director of an undertaking Name of

Undertaking

Nature of Business

Self or partner/ relative

Specific?

Details of directorship held which may be significant to, or relevant to, or bear upon the work of SIGN

Remuneration as a partner in a firm

Name of Partnership

Nature of Business

Self or partner/ relative

Specific?

Details of Partnership held which may be significant to, or relevant to, or bear upon the work of SIGN

Shares and securities

Description of organisation

Description of nature of holding (value need not be

disclosed)

Self or partner/ relative

Specific?

Details of interests in shares and securities in commercial healthcare companies, organisations and undertakings

Remuneration from consultancy or other fee paid work commissioned by, or gifts from, commercial healthcare companies, organisations and undertakings

Nature of work For whom undertaken and

frequency

Self or partner/ relative

Specific?

Details of consultancy or other fee paid work which may be significant of to, or relevant to, or bear upon the work of SIGN

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Details of gifts which may be significant to, or relevant to, or bear upon the work of SIGN

Non-financial interests

Description of interest Self or partner/ relative

Specific?

Details of non-financial interests which may be significant to, or relevant to, or bear upon the work of SIGN

Non-personal interests Name of company, organisation or

undertaking

Nature of interest

Details of non- personal support from commercial healthcare companies, organisations or undertakings

 

Signature Date:

Thank you for completing this form.

Please return to Roberta James SIGN Programme Lead SIGN Executive, Healthcare Improvement Scotland, Gyle Square | 1 South Gyle Crescent | Edinburgh | EH12 9EB t: 0131 623 4735 e:[email protected]

Data Protection

Your details will be stored on a database for the purposes of managing this guideline topic proposal. We may retain your details so that we can contact you about future Healthcare Improvement Scotland activities. We will not pass these details on to any third parties. Please indicate if you do not want your details to be stored after the proposal is published.

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Initial screen

Purpose: initial screening by SIGN Senior Management Team to exclude proposals that are neither clinical, nor multi-professional, nor appropriate for the SIGN process.

1. Is this an appropriate clinical topic for a SIGN guideline? Is it a clinical topic, what is the breadth of the topic and is there a need for the guideline as identified in the proposal?

This proposal looks at low carbohydrate/high fat diet for people with type 2 diabetes as an alternative to pharmacological management in the early stages of the condition. It also cover early identification (prediabetes) to allow early intervention. It is an appropriate topic and would sit alongside or update SIGN 116 on Management of diabetes.

2. Is there a suitable alternative product which would address this topic? Would another Healthcare Improvement Scotland product better address the topic?

No, as SIGN 116 already exists

3. Has this topic been considered before and rejected? What were the reasons for rejection and are they still applicable

No

4. Outcome Go forward to the next stage of topic selection

22/02/17

Reject

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Scope of recent evidence

Summary: Guidelines Three guidelines from the UK and US were identified published between 2009 and 2014. Two of the guidelines cover diagnosis and management of people with type 2 diabetes while the third focuses on nutrition. Health technology assessments No health technology assessments were identified. Cochrane reviews Six Cochrane reviews published between 2005 and 2014. The reviews covered exercise and diet for preventing type 2 diabetes, non pharmacological weight loss interventions for people with prediabetes, dietary treatment for treating type 2 diabetes, including low gycaemic index diets, and culturally appropriate health education. The authors found insufficient evidence on to draw conclusion of the effectiveness of dietary treatment, although weight loss and exercise interventions were associated with a decrease in diabetes incidence. A low-GI diet can improve glycaemic control in diabetes. A further 11 systematic reviews and 654 randomised controlled trials were identified. See Annex 1 for further details

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Suitability screen

Purpose: screening by the Guideline Programme Advisory Board to select applications suitable for inclusion in the SIGN topic selection process.

1. Is there an owner for the project? (preferably an individual)

Yes

2. Is this a clinical priority area for NHSScotland?

Yes, In 2015 there were around 284,000 people registered as having diabetes in Scotland. 88.3% (250,881) of all people registered with diabetes had Type 2 diabetes. Prevalence of diabetes ranged from 4.5% to 6.1% across NHS boards.

3. Is there a gap between current and optimal practice? OR Is there wide variation in current practice? (is this an area of clinical uncertainty)

There is some uncertainty about the role of diet and the type of diet followed in preventing and managing type 2 diabetes.

4. Is there a suitable guideline already available that could be adapted? (not necessarily by SIGN)

SIGN 116 makes recommendations about diet in the lifestyle section.

5. Is there adequate literature to make an evidence-based decision about appropriate practice? (is effective intervention proven and would it reduce mortality or morbidity)

The body of evidence is not large and published systematic reviews have not found enough evidence to provide conclusions of the effectiveness of dietary treatment.

6. Would the proposed practice change result in sufficient change in outcomes (health status, provider and consumer satisfaction and cost) to justify the effort?

Not clear How big is the gap? Not clear

How much effort will it take to close the gap? Not clear

7. Is there a perceived need for the guideline, as indicated by a network of relevant stakeholders?

There is a need for guidance in particular for GPs to help patients find a diet that suits their lifestyle and will achieve their health and wellbeing goals.

8. Is there a reasonable likelihood that NHSScotland could implement the change?

The evidence and professional opinions are conflicting over which diet to recommend so implementing changes would be challenging.

   

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9. Does the proposer have any conflicts of interest? If so how will these be managed?

No

10. Outcome Go forward to the next stage of topic selection

Reject Two meetings with the proposer and a range of healthcare professions led to the conclusion that a review of the evidence would probably not change the recommendation in the current guideline and would not lead to a recommendation for the diet proposed.

YES 06/06/2018

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Annex 1 Scope of recent evidence

Topic: Low Carbohydrate diet for Type 2 Diabetes

Resources searched:

GIN - 1 almost everything in GIN is non-English, old or withdrawn.

National Guidelines Clearinghouse - 1

NICE -1

Cochrane Library -209, sifted to 6

CRD databases

(includes DARE (to 2014) = 25, sifted to 8

HTA = 1, not relevant

NHS EED (to 2014)) = 1, not relevant

INAHTA is the same as UKHTA = 0

Medline for SRs (2014-2017) – 9, sifted to 3

CENTRAL for RCTs (numbers only): 654

Dates searched: 9/3/17-10/3/17

Guidelines

NICE NG28 – Type 2 diabetes in adults: management

https://www.nice.org.uk/guidance/ng28/chapter/1-Recommendations#dietary-advice-2

1.3 Dietary Advice

1.3.1Provide individualised and ongoing nutritional advice from a healthcare professional with specific expertise and competencies in nutrition. [2009]

1.3.2Provide dietary advice in a form sensitive to the person's needs, culture and beliefs, being sensitive to their willingness to change and the effects on their quality of life. [2009]

1.3.3Emphasise advice on healthy balanced eating that is applicable to the general population when providing advice to adults with type 2 diabetes.

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Encourage high-fibre, low-glycaemic-index sources of carbohydrate in the diet, such as fruit, vegetables, wholegrains and pulses; include low-fat dairy products and oily fish; and control the intake of foods containing saturated and trans fatty acids. [2009]

1.3.4Integrate dietary advice with a personalised diabetes management plan, including other aspects of lifestyle modification, such as increasing physical activity and losing weight. [2009]

1.3.5For adults with type 2 diabetes who are overweight, set an initial body weight loss target of 5–10%. Remember that lesser degrees of weight loss may still be of benefit, and that larger degrees of weight loss in the longer term will have advantageous metabolic impact. [2009]

1.3.6Individualise recommendations for carbohydrate and alcohol intake, and meal patterns. Reducing the risk of hypoglycaemia should be a particular aim for a person using insulin or an insulin secretagogue. [2009]

1.3.7Advise adults with type 2 diabetes that limited substitution of sucrose-containing foods for other carbohydrate in the meal plan is allowable, but that they should take care to avoid excess energy intake. [2009]

1.3.8Discourage the use of foods marketed specifically for people with diabetes. [2009]

1.3.9When adults with type 2 diabetes are admitted to hospital as inpatients or to any other care setting, implement a meal planning system that provides consistency in the carbohydrate content of meals and snacks. [2009]

1.3.10For recommendations on lifestyle advice, see the NICE guidelines on: preventing excess weight gain, weight management, obesity, physical activity, smoking: brief interventions and referrals, stop smoking services, smoking: harm reduction, and smoking: acute, maternity and mental health services. [new 2015]

Diagnosis and management of type 2 diabetes mellitus in adults. – Institute for Clinical Systems Improvement

https://www.guideline.gov/summaries/summary/48544

Recommendation

A qualified health professional (which may include a clinician, dietitian, nursing staff and pharmacist) should provide nutrition therapy to a patient diagnosed with T2DM as part of a global treatment plan. [Quality of Evidence: Moderate, Strength of Recommendation: Strong]

Recommendation

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A qualified health care professional (which may include a clinician, nursing staff, pharmacist, and registered dietitian) should counsel a patient diagnosed with T2DM to modify his/her diet to reduce sodium intake to <2,300 mg/day (Strong). Clinicians may counsel patients diagnosed with T2DM and hypertension to further reduce their sodium intake (Weak). [Quality of Evidence: High, Strength of Recommendation: Strong/Weak]

Recommendation

A qualified health care professional (which may include a clinician, dietitian, nursing staff and pharmacist) may give a patient diagnosed with T2DM a meal plan that incorporates monitoring carbohydrates. [Quality of Evidence: Moderate, Strength of Recommendation: Weak]

Diabetes type 1 and type 2 evidence-based nutrition practice guideline. – Academy of Nutrition and Dietetics

https://www.guideline.gov/summaries/summary/50138/diabetes-type-1-and-type-2-evidencebased-nutrition-practice-guideline?q=diabetes

DM: Referral for MNT

The RDN, in collaboration with other members of the health care team, should ensure that all adults with type 1 diabetes and type 2 diabetes are referred for MNT. Individuals who have diabetes should receive individualized MNT to achieve treatment goals, preferably provided by a RDN familiar with the components of diabetes MNT.

Strong, Imperative

DM: Individualize Nutrition Prescription

The RDN should individualize the nutrition prescription and implement evidence-based guidelines in collaboration with the adult with diabetes. A variety of eating patterns (combinations of different foods or food groups) are acceptable for the management of diabetes. Personal preferences (e.g., tradition, culture, religion, health beliefs and goals, economics) and metabolic goals should be considered when recommending one eating pattern over another. Treatment decisions should be founded on evidence-based guidelines tailored to individual patient preferences, prognoses and co-morbidities.

Fair, Imperative

DM: Encourage Reduced Energy Healthful Eating Plan for Overweight or Obese Adults with Diabetes

For overweight or obese adults with diabetes, the RDN should encourage a reduced energy, healthful eating plan, with a goal of weight loss, weight loss maintenance and prevention of weight

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gain. Studies based on reduced energy interventions reported significant reductions in HbA1c of 0.3% to 2.0% in adults with type 2 diabetes and of 1.0% to 1.9% in adults with type 1 diabetes, as well as optimization of medication therapy and improved quality of life.

Strong, Conditional

DM: Individualize Macronutrient Composition

The RDN, in collaboration with the adult with diabetes, should individualize the macronutrient composition of the healthful eating plan within the appropriate energy intake. Limited research regarding differing amounts of carbohydrate (39% to 57% of energy) and fat (27% to 40% of energy), reported no significant effects on A1C or insulin levels in adults with diabetes, independent of weight loss. Limited research reports mixed results regarding the effects of the amount of protein (ranging from 0.8 g to 2.0 g per kg per day) on fasting glucose levels and A1C.

Fair, Imperative

DM Type 1 and 2: Carbohydrate Management Strategies

The RDN should educate adults with type 1 diabetes or type 2 diabetes on multiple daily injections (MDI) of insulin or insulin pump therapy on carbohydrate counting using insulin-to-carbohydrate ratios based on his or her abilities, preferences and management goals. Research reports that carbohydrate counting using insulin-to-carbohydrate ratios resulted in significant decreases in A1C of 0.4% to 1.6% and significant increases in quality of life, as well as continued maintenance of these improvements for up to 44 months. The majority of research reported no significant change in weight as a result of this carbohydrate management strategy.

Strong, Conditional

Health Technology Assessments

Cochrane reviews

Attridge M, Creamer J, Ramsden M, Cannings-John R,Hawthorne K. Culturally appropriate health education for people in ethnic minority groups with type 2 diabetes mellitus. Cochrane Database of Systematic Reviews. 2014; 9. [cited: url: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006424.pub3/abstract

Background: Ethnic minority groups in upper-middle-income and high-income countries tend to be socioeconomically disadvantaged and to have a higher prevalence of type 2 diabetes than is seen in the majority population.Objectives: To assess the effectiveness of culturally appropriate health education for people in ethnic minority groups with type 2 diabetes mellitus.Search methods: A systematic literature search was performed of the following databases: The Cochrane Library, MEDLINE, EMBASE, PsycINFO, the Education Resources Information

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Center (ERIC) and Google Scholar, as well as reference lists of identified articles. The date of the last search was July 2013 for The Cochrane Library and September 2013 for all other databases. We contacted authors in the field and handsearched commonly encountered journals as well.Selection criteria: We selected randomised controlled trials (RCTs) of culturally appropriate health education for people over 16 years of age with type 2 diabetes mellitus from named ethnic minority groups residing in upper-middle-income or high-income countries.Data collection and analysis: Two review authors independently assessed trial quality and extracted data. When disagreements arose regarding selection of papers for inclusion, two additional review authors were consulted for discussion. We contacted study authors to ask for additional information when data appeared to be missing or needed clarification.Main results: A total of 33 trials (including 11 from the original 2008 review) involving 7453 participants were included in this review, with 28 trials providing suitable data for entry into meta-analysis. Although the interventions provided in these studies were very different from one study to another (participant numbers, duration of intervention, group versus individual intervention, setting), most of the studies were based on recognisable theoretical models, and we tried to be inclusive in considering the wide variety of available culturally appropriate health education.Glycaemic control (as measured by glycosylated haemoglobin A1c (HbA1c)) showed improvement following culturally appropriate health education at three months (mean difference (MD) -0.4% (95% confidence interval (CI) -0.5 to -0.2); 14 trials; 1442 participants; high-quality evidence) and at six months (MD -0.5% (95% CI -0.7 to -0.4); 14 trials; 1972 participants; high-quality evidence) post intervention compared with control groups who received 'usual care'. This control was sustained to a lesser extent at 12 months (MD -0.2% (95% CI -0.3 to -0.04); 9 trials; 1936 participants) and at 24 months (MD -0.3% (95% CI -0.6 to -0.1); 4 trials; 2268 participants; moderate-quality evidence) post intervention. Neutral effects on health-related quality of life measures were noted and there was a general lack of reporting of adverse events in most studies - the other two primary outcomes for this review. Knowledge scores showed improvement in the intervention group at three (standardised mean difference (SMD) 0.4 (95% CI 0.1 to 0.6), six (SMD 0.5 (95% CI 0.3 to 0.7)) and 12 months (SMD 0.4 (95% CI 0.1 to 0.6)) post intervention. A reduction in triglycerides of 24 mg/dL (95% CI -40 to -8) was observed at three months, but this was not sustained at six or 12 months. Neutral effects on total cholesterol, low-density lipoprotein (LDL) cholesterol or high-density lipoprotein (HDL) cholesterol were reported at any follow-up point. Other outcome measures (blood pressure, body mass index, self-efficacy and empowerment) also showed neutral effects compared with control groups. Data on the secondary outcomes of diabetic complications, mortality and health economics were lacking or were insufficient.Because of the nature of the intervention, participants and personnel delivering the intervention were rarely blinded, so the risk of performance bias was high. Also, subjective measures were assessed by participants who self-reported via questionnaires, leading to high bias in subjective outcome assessment.Authors' conclusions: Culturally appropriate healt education has short- to medium-term effects on glycaemic control and on knowledge of diabetes and healthy lifestyles. With this update (six years after the first publication of this review), a greater number of RCTs were reported to be of sufficient quality for inclusion in the review. None of these studies were long-term trials, and so clinically important long-term outcomes could not be studied. No studies included an economic analysis. The heterogeneity of the studies made subgroup comparisons difficult to interpret with confidence. Long-term, standardised, multi-centre RCTs are needed to compare different types and intensities of culturally appropriate health education within defined ethnic minority groups, as the medium-term effects could lead to clinically important health outcomes, if sustained.

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Nield L, Moore H, Hooper L, Cruickshank K, Vyas A, Whittaker V, et al. Dietary advice for treatment of type 2 diabetes mellitus in adults. Cochrane Database of Systematic Reviews. 2007; 3. [cited: url: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004097.pub4/abstract

Background: While initial dietary management immediately after formal diagnosis is an 'accepted' cornerstone of treatment of type 2 diabetes mellitus, a formal and systematic overview of its efficacy and method of delivery is not currently available.Objectives: To assess the effects of type and frequency of different types of dietary advice for adults with type 2 diabetes.Search methods: We carried out a comprehensive search of The Cochrane Library, MEDLINE, EMBASE, CINAHL, AMED, bibliographies and contacted relevant experts.Selection criteria: All randomised controlled trials, of six months or longer, in which dietary advice was the main intervention.Data collection and analysis: The lead investigator performed all data extraction and quality scoring with duplication being carried out by one of the other six investigators independently with discrepancies resolved by discussion and consensus. Authors were contacted for missing data.Main results: Thirty-six articles reporting a total of eighteen trials following 1467 participants were included. Dietary approaches assessed in this review were low-fat/high-carbohydrate diets, high-fat/low-carbohydrate diets, low-calorie (1000 kcal per day) and very-low-calorie (500 kcal per day) diets and modified fat diets. Two trials compared the American Diabetes Association exchange diet with a standard reduced fat diet and five studies assessed low-fat diets versus moderate fat or low-carbohydrate diets. Two studies assessed the effect of a very-low-calorie diet versus a low-calorie diet. Six studies compared dietary advice with dietary advice plus exercise and three other studies assessed dietary advice versus dietary advice plus behavioural approaches. The studies all measured weight and measures of glycaemic control although not all studies reported these in the articles published. Other outcomes which were measured in these studies included mortality, blood pressure, serum cholesterol (including LDL and HDL cholesterol), serum triglycerides, maximal exercise capacity and compliance. The results suggest that adoption of regular exercise is a good way to promote better glycaemic control in type 2 diabetic patients, however all of these studies were at high risk of bias.Authors' conclusions: There are no high quality data on the efficacy of the dietary treatment of type 2 diabetes, however the data available indicate that the adoption of exercise appears to improve glycated haemoglobin at six and twelve months in people with type 2 diabetes. There is an urgent need for well-designed studies which examine a range of interventions, at various points during follow-up, although there is a promising study currently underway.

Norris Susan L, Zhang X, Avenell A, Gregg E, Schmid Christopher H,Lau J. Long-term non-pharmacological weight loss interventions for adults with prediabetes. Cochrane Database of Systematic Reviews. 2005; 2. [cited: url: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD005270/abstract

Background: Most persons with prediabetes (impaired glucose tolerance or impaired fasting glucose) are overweight, and obesity worsens the metabolic and physiologic abnormalities associated with this condition. Prediabetes is an important risk factor for the development of type 2 diabetes.Objectives: The objective of this review was to assess the effectiveness of dietary, physical activity, and behavioral weight loss, and weight control interventions for adults with prediabetes.Search methods: Studies were obtained from computerized searches of multiple electronic bibliographic dababases, supplemented by hand searches of selected journals, and consultation with experts in obesity research. The last search was conducted May, 2004.Selection criteria: Studies were included if they were published or unpublished randomized controlled trials in

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any language and examined weight loss or weight control strategies using one or more dietary, physical activity, or behavioral interventions, with a follow-up interval of at least 12 months.Data collection and analysis: Effects were combined using a random-effects model.Main results: Nine studies were identified, with a total of 5,168 participants. Follow-up ranged from 1 to 10 years. Quantitative synthesis was limited by the heterogeneity of populations, settings, and interventions and by the small number of studies that examined outcomes other than weight. Overall, in comparisons with usual care, four studies with a follow-up of one year reduced weight by 2.8 kg (95 % confidence interval (CI) 1.0 to 4.7) (3.3% of baseline body weight) and decreased body mass index by 1.3 kg/m2 (95% CI 0.8 to 1.9). Weight loss at two years was 2.6 kg (95% CI 1.9 to 3.3) (three studies). Modest improvements were noted in the few studies that examined glycemic control, blood pressure, or lipid concentrations (P > 0.05). No data on quality of life or mortality were found. The incidence of diabetes was significantly lower in the intervention groups versus the controls in three of five studies examining this outcome at 3 to 6 years follow-up.Authors' conclusions: Overall, weight loss strategies using dietary, physical activity, or behavioral interventions produced significant improvements in weight among persons with prediabetes and a significant decrease in diabetes incidence. Further work is needed on the long-term effects of these interventions on morbidity and mortality and on how to implement these interventions in diverse community settings.

Ooi Cheow P,Loke Seng C. Sweet potato for type 2 diabetes mellitus. Cochrane Database of Systematic Reviews. 2013; 9. [cited: url: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009128.pub3/abstract

Background: Sweet potato (Ipomoea batatas) is among the most nutritious subtropical and tropical vegetables. It is also used in traditional medicine practices for type 2 diabetes mellitus. Research in animal and human models suggests a possible role of sweet potato in glycaemic control.Objectives: To assess the effects of sweet potato for type 2 diabetes mellitus.Search methods: We searched several electronic databases, including The Cochrane Library (2013, Issue 1), MEDLINE, EMBASE, CINAHL, SIGLE and LILACS (all up to February 2013), combined with handsearches. No language restrictions were used.Selection criteria: We included randomised controlled trials (RCTs) that compared sweet potato with a placebo or a comparator intervention, with or without pharmacological or non-pharmacological interventions.Data collection and analysis: Two authors independently selected the trials and extracted the data. We evaluated risk of bias by assessing randomisation, allocation concealment, blinding, completeness of outcome data, selective reporting and other potential sources of bias.Main results: Three RCTs met our inclusion criteria: these investigated a total of 140 participants and ranged from six weeks to five months in duration. All three studies were performed by the same trialist. Overall, the risk of bias of these trials was unclear or high. All RCTs compared the effect of sweet potato preparations with placebo on glycaemic control in type 2 diabetes mellitus. There was a statistically significant improvement in glycosylated haemoglobin A1c (HbA1c) at three to five months with 4 g/day sweet potato preparation compared to placebo (mean difference -0.3% (95% confidence interval -0.6 to -0.04); P = 0.02; 122 participants; 2 trials). No serious adverse effects were reported. Diabetic complications and morbidity, death from any cause, health-related quality of life, well-being, functional outcomes and costs were not investigated.Authors' conclusions: There is insufficient evidence about the use of sweet potato for type 2 diabetes mellitus. In addition to improvement in trial methodology, issues of standardization and quality control of preparations - including other varieties of sweet potato - need to be addressed. Further observational trials and RCTs evaluating the effects of sweet potato are needed to guide any recommendations in clinical practice.

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Orozco Leonardo J, Buchleitner Ana M, Gimenez-Perez G, Roqué i Figuls M, Richter B,Mauricio D. Exercise or exercise and diet for preventing type 2 diabetes mellitus. Cochrane Database of Systematic Reviews. 2008; 3. [cited: url: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003054.pub3/abstract

Background: The incidence of type 2 diabetes is associated with the 'Westernised lifestyle', mainly in terms of dietary habits and physical activity. Thus an intensive diet and exercise intervention might prevent or delay the appearance of diabetes in persons at high risk.Objectives: To assess the effects of exercise or exercise and diet for preventing type 2 diabetes mellitus.Search methods: We searched The Cochrane Library, MEDLINE, EMBASE, CINAHL, LILACS, SocioFile, databases of ongoing trials and reference lists of relevant reviews.Selection criteria: Studies were included if they were randomised controlled trials of exercise and diet interventions of at least six month duration and reported diabetes incidence in people at risk for type 2 diabetes.Data collection and analysis: Two authors independently assessed trial quality and extracted data. Study authors were contacted to obtain missing data. Data on diabetes incidence and secondary outcomes were analysed by means of random-effects meta-analysis.Main results: We included eight trials that had an exercise plus diet (2241 participants) and a standard recommendation arm (2509 participants). Two studies had a diet only (167 participants) and exercise only arm (178 participants). Study duration ranged from one to six years. Overall, exercise plus diet interventions reduced the risk of diabetes compared with standard recommendations (RR 0.63, 95% CI 0.49 to 0.79). This had also favourable effects on weight and body mass index reduction, waist-to-hip ratio and waist circumference. However, statistical heterogeneity was very high for these outcomes. Exercise and diet interventions had a very modest effect on blood lipids. However, this intervention improved systolic and diastolic blood pressure levels (weighted mean difference -4 mmHg, 95% CI -5 to -2 and -2 mmHg, 95% CI -3 to -1, respectively). No statistical significant effects on diabetes incidence were observed when comparing exercise only interventions either with standard recommendations or with diet only interventions. No study reported relevant data on diabetes and cardiovascular related morbidity, mortality and quality of life.Authors' conclusions: Interventions aimed at increasing exercise combined with diet are able to decrease the incidence of type 2 diabetes mellitus in high risk groups (people with impaired glucose tolerance or the metabolic syndrome). There is a need for studies exploring exercise only interventions and studies exploring the effect of exercise and diet on quality of life, morbidity and mortality, with special focus on cardiovascular outcomes.

Thomas D,Elliott Elizabeth J. Low glycaemic index, or low glycaemic load, diets for diabetes mellitus. Cochrane Database of Systematic Reviews. 2009; 1. [cited: url: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006296.pub2/abstract

Background: The aim of diabetes management is to normalise blood glucose levels, since improved blood glucose control is associated with reduction in development, and progression, of complications. Nutritional factors affect blood glucose levels, however there is currently no universal approach to the optimal dietary treatment for diabetes. There is controversy about how useful the glycaemic index (GI) is in diabetic meal planning. Improved glycaemic control through diet could minimise medications, lessen risk of diabetic complications, improve quality of life and increase life expectancy.Objectives: To assess the effects of low glycaemic index, or low glycaemic load, diets on glycaemic control in people with diabetes.Search methods: We performed

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electronic searches of The Cochrane Library, MEDLINE, EMBASE and CINAHL with no language restriction.Selection criteria: We assessed randomised controlled trials of four weeks or longer that compared a low glycaemic index, or low glycaemic load, diet with a higher glycaemic index, or load, or other diet for people with either type 1 or 2 diabetes mellitus, whose diabetes was not already optimally controlled.Data collection and analysis: Two reviewers independently extracted data on study population, intervention and outcomes for each included study, using standardised data extraction forms. Main results: Eleven relevant randomised controlled trials involving 402 participants were identified. There was a significant decrease in the glycated haemoglobin A1c (HbA1c) parallel group of trials, the weighted mean difference (WMD) was -0.5% with a 95% confidence interval (CI) of - 0.9 to -0.1, P = 0.02; and in the cross-over group of trials the WMD was -0.5% with a 95% CI of -1.0 to -0.1, P = 0.03. Episodes of hypoglycaemia were significantly fewer with low compared to high GI diet in one trial (difference of -0.8 episodes per patient per month, P < 0.01), and proportion of participants reporting more than 15 hyperglycaemic episodes per month was lower for low-GI diet compared to measured carbohydrate exchange diet in another study (35% versus 66%, P = 0.006). No study reported on mortality, morbidity or costs. Authors' conclusions: A low-GI diet can improve glycaemic control in diabetes without compromising hypoglycaemic events.

Other Systematic reviews

1 Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes (Structured abstract). American Journal of Clinical Nutrition 2013; 97: 505-16.

2 Bravata DM, Sanders L, Huang J, Krumholz HM, Olkin I, Gardner CD, et al. Efficacy and safety of low-carbohydrate diets: a systematic review (Structured abstract). Jama 2003; 289: 1837-50.

3 Cao Y, Mauger DT, Pelkman CL, Zhao G, Townsend SM, Kris-Etherton PM. Effects of moderate (MF) versus lower fat (LF) diets on lipids and lipoproteins: a meta-analysis of clinical trials in subjects with and without diabetes (Structured abstract). Journal of Clinical Lipidology 2009; 3: 19-32.

4 Castaneda-Gonzalez LM, Bacardi Gascon M, Jimenez Cruz A. Effects of low carbohydrate diets on weight and glycemic control among type 2 diabetes individuals: a systemic review of RCT greater than 12 weeks (Structured abstract). Nutricion Hospitalaria 2011; 26: 1270-6.

5 Hu T, Mills KT, Yao L, Demanelis K, Eloustaz M, Yancy WS, et al. Effects of low-carbohydrate diets versus low-fat diets on metabolic risk factors: a meta-analysis of randomized controlled clinical trials (Structured abstract). American Journal of Epidemiology 2012; 176: S44-s54.

6 Johnson ST, Newton AS, Chopra M, Buckingham J, Huang TT, Franks PW, et al. In search of quality evidence for lifestyle management and glycemic control in children and adolescents with type 2 diabetes: a systematic review (Structured abstract). BMC Pediatrics 2010; 10:97:

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7 Kirk JK, Graves DE, Craven TE, Lipkin EW, Austin M, Margolis KL. Restricted-carbohydrate diets in patients with type 2 diabetes: a meta-analysis (Structured abstract). Journal of the American Dietetic Association 2008; 108: 91-100.

8 Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Sato M, et al. Influence of fat and carbohydrate proportions on the metabolic profile in patients with type 2 diabetes: a meta-analysis (Structured abstract). Diabetes Care 2009; 32: 959-65.

9 Naude CE, Schoonees A, Senekal M, Young T, Garner P, Volmink J. Low carbohydrate versus isoenergetic balanced diets for reducing weight and cardiovascular risk: a systematic review and meta-analysis. PLoS ONE [Electronic Resource] 2014;9(7):e100652.

10 Tobias DK, Chen M, Manson JE, Ludwig DS, Willett W, Hu FB. Effect of low-fat diet interventions versus other diet interventions on long-term weight change in adults: a systematic review and meta-analysis. The Lancet Diabetes & Endocrinology 2015;3(12):968-79.

11 van Wyk HJ, Davis RE, Davies JS. A critical review of low-carbohydrate diets in people with Type 2 diabetes. Diabetic Medicine 2016;33(2):148-57.

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Annex 2 Proposer references

Low-carb, Hope, & Choice in Type 2 Diabetes for interested GPs who want to make a difference

David Unwin FRCGP Would any of us say that glucose was good nutrition for someone with Type 2 diabetes? For decades until the advent of insulin and the drugs for diabetes restricting sources of glucose was the only treatment for diabetes. People with T2D struggle to metabolise glucose; for them it is a sort of metabolic poison which makes even ‘moderate’ consumption unwise. A separate issue is both the expense and how patients feel about starting lifelong medication. For four years I have offered my patients the alternative choice of closer dietary supervision, and usually weight loss, to starting metformin and not a single patient has asked to start medication. (given that metformin gives GI side effects in 26% of cases –a wise choice)  For 25 years in partnership I never saw a single patient reverse their diabetes. It was always a progressive, deteriorating condition where I added in repeat medication, often as they gained weight, with all the other medical baggage that ushers in. Now my 9000 patient practice manages to get around 25% remission rates for our T2D (HbA1c <42 mmol/mol) with an average weight loss of 8.5Kg and an improvement in HbA1c of 20 mmol/mol This gives great hope to clinicians and patients alike, engendering a far more cheerful, collaborative approach.  

     Our knowledge about how to predict what foods affected post‐prandial blood sugars was advanced by the Glycaemic index about 30 years ago, which is why this is enshrined in the latest NICE guidelines, along with individual patient preferences.       

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   NICE diabetes guidelines Dec 2015 'Treatment and care should take into account individual needs and preferences. Patients should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals’ 1.3.3 Encourage highfibre, lowglycaemicindex sources of carbohydrate in the diet  1.3.6 Individualise recommendations for carbohydrate and alcohol intake

Perhaps calling it low carb is the contentious bit, what does this mean?  Briefly in my practice I am inviting patients with T2D to think about the sources of glucose in their diet as predicted by the glycaemic index (which can also be used to suggest alternative less glycaemic alternatives) to help them make sensible choices while advising them to notice what seems to suit them best, and at the same time to watch their weight. The first step is to eliminate table sugar and unhealthy snacks, but that is not always enough. Many are amazed to discover that nearly all bread has a high index. For example a small slice of brown bread is glycaemicaly equivalent to three teaspoons of sugar. At the same time I introduce the idea that their efforts can make a huge difference to their health, and that lifelong medication may not be needed after all. 

 This against a background of information that real foods like green leafy veg, lower glycaemic fruits like raspberries or blueberries, meat ,fish, nuts, eggs and full fat dairy may well be better than packeted foods. So far I have a case series of over 90 happy, proud patients with results I was quite unable to achieve over my first 25 years in practice using a conventional approach. I suspect that at the end of the day T2D is for the majority of patients still about dietary sources and burden of glucose.   Because of the wonderful variability of people’s lives the actual diet they choose is as varied as they are, this makes defining any particular diet for study purposes very difficult unless they are kept in laboratory conditions. Also asking patients to keep food diaries is an imposition. We find it’s better to measure outcomes like weight HbA1c etc. after specific advice and information 

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rather than estimate dietary intakes. The patient feedback is that they are amazed not to feel hungry on the diet and this together with the fact that there is no measuring or weighing of food makes it more of a sustainable lifestyle than a diet.  Evidence for the low carb approach  I attach 55 RCTs for this, the table of 55 low‐carb v low‐fat RCTs is hosted on the PHC website, https://www.PHCuk.org/RCTs which needs comparing to the evidence for say metformin: Metformin has been considered the best first line drug for type 2 diabetes since 1998. The UKPDS 34 study, on which the recommendation is based has never been reproduced. The reproducibility of results is an essential scientific validity criterion, also these results were obtained in a subgroup of just 753 obese patients. Meta‐analyses of randomised controlled trials evaluating the effectiveness of metformin in patients with type 2 diabetes found that metformin did not significantly modify clinically relevant outcomes.  The analysis of all types of trial shows no efficacy of metformin at all. No placebo controlled trial has ever unambiguously shown that metformin reduces microvascular and macrovascular complications (Metformin as first line treatment for type 2 diabetes: are we sure? Published 08 January 2016 BMJ 2016;352:h6748 Rémy Boussageon)   Low‐carb meta‐analysis 1. Sackner‐Bernstein J, Kanter D, Kaul S (2015) Dietary Intervention for Overweight and Obese Adults: Comparison of Low‐Carbohydrate and Low‐Fat Diets. A Meta‐Analysis. PLoS ONE 10(10): e0139817. doi: 10.1371/journal.pone.0139817  Published in the Journal PLOS ONE, a meta‐analysis of seventeen randomized clinical trials provides insight into the relative benefits of low‐carbohydrate and low‐fat diets in terms of weight lost, cholesterol events. The seventeen clinical trials used for meta‐analysis included a total of 1,797 patients over the age of eighteen who all lacked co‐morbidities other than dyslipidemia. Each trial randomly assigned patients to treatment groups and included at least eight weeks of follow‐up.  The results of the meta‐analysis indicated that both low‐carbohydrate and low‐fat dietary interventions resulted in weight loss (7.8 and 5.9 kilograms of weight lost respectively). Results, however, favoured the low‐carbohydrate intervention for seven of the seventeen trials while none of the trials favoured the low‐fat intervention.  Overall, patients in the low‐carbohydrate intervention groups lost two kilograms more than those in low‐fat treatment groups.  Low‐carb meta‐analysis 2. In 2013 Bueno et al published a meta‐analysis on very‐low‐carb diets, http://www.ncbi.nlm.nih.gov/pubmed/23651522   Yearly ££ saving at my surgery, against our CCG average on drugs for diabetes (BNF 6.1.) = approx. £45,569.50

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Also part of the approach. We run a weekly nurse led evening low carb clinic backed up by a monthly GP 

partner low carb surgery. Currently we hold a bi‐monthly group low carb education evening for about 25 

patients and interested family members too    

No one ever thanked me for starting metformin, yet now I am thanked on a daily basis for this approach. Are you interested to try and make a difference? Dr David Unwin FRCGP RCGP National Champion for Collaborative Care and Support Planning in Obesity & Diabetes RCGP clinical expert in diabetes NHS Innovator of the year 2016 Norwood Surgery 11 Norwood Ave Southport Follow @lowcarbGP http://www.diabesityinpractice.co.uk/media/content/_master/4311/files/pdf/dip4-3-102-8.pdf

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Randomised controlled trials comparing low carb diets of less than 130g carbohydrates/day to low fat diets of less than 35% fat of total calories [11] Short-term effects of severe dietary carbohydrate-restriction advice in Type 2 diabetes—a randomized controlled trial. Daly et al. http://onlinelibrary.wiley.com/doi/10.1111/j.1464-5491.2005.01760.x/abstract [16] The effect of a low-carbohydrate, ketogenic diet versus a low-glycemic index diet on glycemic control in type 2 diabetes mellitus. Westman et al. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2633336/ [23] In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss. Guldbrand et al. http://link.springer.com/article/10.1007/s00125-012-2567-4/fulltext.html [24] A Randomized Pilot Trial of a Moderate Carbohydrate Diet Compared to a Very Low Carbohydrate Diet in Overweight or Obese Individuals with Type 2 Diabetes Mellitus or Prediabetes. Saslow et al. http://www.plosone.org/article/info:doi/10.1371/journal.pone.0091027 [28] Comparative Study of the Effects of a 1-Year Dietary Intervention of a Low-Carbohydrate Diet Versus a Low-Fat Diet on Weight and Glycemic Control in Type 2 Diabetes. Davis et al. http://care.diabetesjournals.org/content/32/7/1147 [37] A very low-carbohydrate, low-saturated fat diet for type 2 diabetes management: a randomized trial. Tay et al. http://www.ncbi.nlm.nih.gov/pubmed/25071075 [43] Advice to follow a low-carbohydrate diet has a favourable impact on low-grade inflammation in type 2 diabetes compared with advice to follow a low-fat diet. Jonasson et al. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4025600/ [44] A non-calorie-restricted low-carbohydrate diet is effective as an alternative therapy for patients with type 2 diabetes. Yamada et al. http://www.ncbi.nlm.nih.gov/pubmed/24390522 [51] Comparison of low- and high-carbohydrate diets for type 2 diabetes management: a randomized trial. Tay et al. http://ajcn.nutrition.org/content/early/2015/07/29/ajcn.115.112581.abstract [54] A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control. Sato et al. http://www.clinicalnutritionjournal.com/article/S0261-5614(16)30169-8/pdf [55] Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. Goday et al. http://www.nature.com/nutd/journal/v6/n9/full/nutd201636a.html Adams LA, Lymp JF, St Sauver J et al (2005) The natural history of nonalcoholic fatty liver disease: a population-based cohort study. Gastroenterology 129: 113–21 Anstee QM, McPherson S, Day CP (2011) How big a problem is non- alcoholic fatty liver disease? BMJ 343: d3897 Anstee QM, Targher G, Day CP (2013) Progression of NAFLD to diabetes mellitus, cardiovascular disease or cirrhosis. Nat Rev Gastroenterol Hepatol 10: 330–44 Banting W (1863) Letter on Corpulence, Addressed to the Public (London, 1863). Harrison, London

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Browning JD, Baker JA, Rogers T et al (2011) Short-term weight loss and hepatic triglyceride reduction: evidence of a metabolic advantage with dietary carbohydrate restriction. Am J Clin Nutr 93: 1048–52 Chalasani N, Younossi Z, Lavine JE et al (2012) The diagnosis and management of non-alcoholic fatty liver disease: Practice guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Am J Gastroenterol 107: 811–26 Dixon JB, Bhathal PS, O’Brien PE (2006) Weight loss and non-alcoholic fatty liver disease: falls in gamma-glutamyl transferase concentrations are associated with histologic improvement. Obes Surg 16: 1278–86 Erlanson-Albertsson C, Mei J (2005) The effect of low carbohydrate on energy metabolism. Int J Obes (Lond) 29(Suppl 2): S26–S30 Feinman RD, Pogozelski WK, Astrup A et al (2015) Dietary carbohydrate restriction as the first approach in diabetes management: critical review and evidence base. Nutrition 31: 1–13 Foster-Powell K, Holt SH, Brand-Miller JC (2002) International table of glycemic index and glycemic load values: 2002. Am J Clin Nutr 76: 5–56 Fraser A, Harris R, Sattar N et al (2009) Alanine aminotransferase, gamma-glutamyltransferase, and incident diabetes: the British Women’s Heart and Health Study and meta-analysis. Diabetes Care 32: 741–50 Gannon MC, Nuttall FQ (2006) Control of blood glucose in type 2 diabetes without weight loss by modification of diet composition. Nutr Metab (Lond) 3: 16 Haufe S, Engeli S, Kast P et al (2011) Randomized comparison of reduced fat and reduced carbohydrate hypocaloric diets on intrahepatic fat in overweight and obese human subjects. Hepatology 53: 1504–14 Lam C, Babu S (2015) Non-alcoholic fatty liver disease and diabesity. Diabesity in Practice 4: 64–9 Lee DS, Evans JC, Robins SJ et al (2007) Gamma glutamyl transferase and metabolic syndrome, cardiovascular disease, and mortality risk: the Framingham Heart Study. Arterioscler Thromb Vasc Biol 27: 127–33 Marchesini G, Avagnina S, Barantani EG et al (2005) Aminotransferase and gamma-glutamyltranspeptidase levels in obesity are associated with insulin resistance and the metabolic syndrome. J Endocrinol Invest 28: 333–9 Mofrad P, Contos MJ, Haque M et al (2003) Clinical and histologic spectrum of nonalcoholic fatty liver disease associated with normal ALT values. Hepatology 37: 1286–92 Musso G, Cassader M, Rosina F et al (2012) Impact of current treatments on liver disease, glucose metabolism and cardiovascular risk in non- alcoholic fatty liver disease (NAFLD): a systematic review and meta- analysis of randomised trials. Diabetologia 55: 885–904 Nielsen JV, Joensson EA (2008) Low-carbohydrate diet in type 2 diabetes: stable improvement of bodyweight and glycemic control during 44 months follow-up. Nutr Metab (Lond) 5: 14 Ogden J, Wardle J (1990) Cognitive restraint and sensitivity to cues for hunger and satiety. Physiol Behav 47: 477–81

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Perry IJ, Wannamethee SG, Shaper AG (1998) Prospective study of serum gamma-glutamyltransferase and risk of NIDDM. Diabetes Care 21: 732–7 Preiss D, Sattar N (2008) Non-alcoholic fatty liver disease: an overview of prevalence, diagnosis, pathogenesis and treatment considerations. Clin Sci (Lond) 115: 141–50 Rollo J (1797) Diabetes mellitus: an account of two cases of diabetes mellitus: with remarks as they arose during the progress of the cure. Ann Med 85–106 Taylor R (2013) Banting Memorial Lecture 2012: Reversing the twin cycles of type 2 diabetes. Diabet Med 30: 267–75 Unwin D (2014) Diabesity: Perhaps we can make a difference after all? Diabesity in Practice 3: 131–4 Unwin D, Unwin J (2014) Low carbohydrate diet to achieve weight loss and improve HbA1c in type 2 diabetes and pre-diabetes: experience from one general practice. Practical Diabetes 31: 76–9 Volek JS, Feinman RD (2005) Carbohydrate restriction improves the features of Metabolic Syndrome. Metabolic Syndrome may be defined by the response to carbohydrate restriction. Nutr Metab (Lond) 2: 31 Westman EC, Yancy WS Jr, Humphreys M (2006) Dietary treatment of diabetes mellitus in the pre-insulin era (1914-1922). Perspect Biol Med 49: 77–83 Eat-Fat-Cut-The-Carbs-and-Avoid-Snacking-To-Reverse-Obesity-and-Type-2-Diabetes-National-Obesity-Forum-Public-Health-Collaboration https://phcuk.org/wp-content/uploads/2016/05/Eat-Fat-Cut-The-Carbs-and-Avoid-Snacking-To-Reverse-Obesity-and-Type-2-Diabetes-National-Obesity-Forum-Public-Health-Collaboration.pdf Identifying prediabetes using fasting insulin levels https://www.ncbi.nlm.nih.gov/pubmed/19789156 http://www.diabesityinpractice.co.uk/journal-content/view/a-pilot-study-to-explore-the-role-of-a-low-carbohydrate-intervention-to-improve-ggt-levels-and-hba1c