The Diabetes Remission Clinical Trial (DiRECT): Protocol for a cluster randomised trial

BMC Family Practice

Volumn 17, Issue 1, 2016, Pages

  Leslie, Wilma S ^a   Ford, Ian ^a   Sattar, Naveed ^a   Hollingsworth, Kieren G ^b   Adamson, Ashley ^b   Sniehotta, Falko F ^b   McCombie, Louise ^c   Brosnahan, Naomi ^a   Ross, Hazel ^c   Mathers, John C ^b   Peters, Carl ^b   Thom, George ^a   Barnes, Alison ^b   Kean, Sharon ^a   McIlvenna, Yvonne ^a   Rodrigues, Angela ^b   Rehackova, Lucia ^b   Zhyzhneuskaya, Sviatlana ^b   Taylor, Roy ^b   Lean, Mike E J ^a  

^a UNIVERSITY OF GLASGOW   (United Kingdom)

^b NEWCASTLE UNIVERSITY   (United Kingdom)

^c Counterweight Ltd ^*  (United Kingdom)

Author keywords

Primary care; Total diet replacement; Type 2 diabetes; Weight management

Indexed keywords

ANTIDIABETIC AGENT; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN;

ADULT; AGED; COMPLICATION; CONTROLLED STUDY; DIABETES MELLITUS, TYPE 2; ENGLAND; FEMALE; HUMAN; LOW CALORY DIET; MALE; METABOLISM; MIDDLE AGED; OBESITY; PRIMARY HEALTH CARE; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; REMISSION; SCOTLAND; WEIGHT LOSS PROGRAM; YOUNG ADULT;

ADULT; AGED; DIABETES MELLITUS, TYPE 2; DIET, REDUCING; ENGLAND; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; OBESITY; PRIMARY HEALTH CARE; REMISSION INDUCTION; SCOTLAND; WEIGHT REDUCTION PROGRAMS; YOUNG ADULT;

EID: 84958149205     PISSN: None     EISSN: 14712296     Source Type: Journal    
DOI: 10.1186/s12875-016-0406-2     Document Type: Article

References (34)

1. Walker A. The cost of doing nothing: the economics of obesity in Scotland. Robertson Centre for Biostatistics, University of Glasgow, June 2003.
2. Chan JM, Rimm EB, Colditz GA, Stampfer MJ, Willett WC. Obesity, fat distribution and weight gain as risk factors for clinical diabetes in men. Diab Care. 1994;17(9):961-9.
3. UKPDS. UK Prospective Diabetes Study (UKPDS) VIII. Study, design, progress and performance. Diabetol. 1991;34(12):877-90.
4. Lean ME, Powrie JK, Anderson AS, Garthwaite PH. Obesity, weight loss and prognosis in type 2 diabetes. Diabet Med. 1990;7(3):228-33.
5. Scottish Health Survey. 2008. http://www.scotland.gov.uk/Publications/2009/09/28102003/0 (accessed May 2012)
6. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walkder EA, et al. Diabetes Prevention Programme Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. NEJM. 2002;346:393-403.
7. Penn L, White M, Lindström J, den Boer AT, Blaak E, Eriksson JG, et al. Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT. PLoS One. 2013;8(2), e57143.
8. Miras AD, Chuah LL, Lascaratos G, Faruq S, Mohite AA, Shah PR, et al. Bariatric Surgery Does not Exacerbate and may be beneficial for the Microvascular complications of Type 2 Diabetes. Diab Care. 2012;35:e81.
9. Rowe R, Cowx M, Poole C, McEwan P, Morgan C, Walker M. The effects of orlistat in patients with diabetes: improvement in glycaemic control and weight loss. Curr Med Res Opin. 2005;21(11):1885-90.
10. Redmon JB, Bertoni AG, Connelly S, Feeney PA, Glasser SP, Glick H, et al. Effect of the look AHEAD study intervention on medication use and related cost to treat cardiovascular disease risk factors in individuals with type 2 diabetes. Diab Care. 2010;33(6):1153-8.
11. SIGN. Management of obesity No 115. http://www.sign.ac.uk/pdf/sign115.pdf (accessed May 2012)
12. NICE: obesity guidelines. 2006. http://www.nice.org.uk/nicemedia/pdf/CG43NICEGuideline.pdf (accessed May 2012)
13. Quality and Outcomes Framework (QOF). http://www.isdscotland.org/Health-Topics/General-Practice/Quality-And-Outcomes-Framework/ http://www.hscic.gov.uk/qof
14. Dixon JB, O'Brien PE, Playfair J, Chapman L, Schachter LM, Skinner S, et al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomised controlled trial. JAMA. 2008;299(3):316-23.
15. Gregg EW, Chen H, Wagenknecht LE, Clark JM, Delahanty LM, Bantle J, et al. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA. 2012;308(23):2489-96.
16. Lim EL, Kg H, Aribisala BS, Chen MJ, Mathers JC, Taylor R. Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetol. 2011;54:2506-14.
17. Guidone C, Manco M, Valera-Mora E, Iaconelli A, Gniuli D, Mari A, et al. Mechanisms of recovery from type 2 diabetes after malabsorptive bariatric surgery. Diabetes. 2006;55(7):2025-31.
18. Steven S, Carey PE, Small PK, Taylor R. Reversal of Type 2 diabetes after bariatric surgery is determined by the degree of achieved weight loss in both short- and long-duration diabetes. Diabetic Medicine. 2015;32(1):47-53. doi: 10.1111/dme.12567. PMID: 25132043, Epub 2014 Sep 12.
19. Taylor R. Type 2 diabetes: etiology and reversibility. Diabetes Care. 2013;36(4):1047-55. doi: 10.2337/dc12-1805.
20. Stevens S, Lim EL, Taylor R. Population response to the reversibility of Type 2 diabetes. Diabet Med. 2013;30:e135-8.
21. Lean M, Brosnahan N, McCloone P, McCombie L, Biggs AB, Ross H, et al. Feasibility and indicative results from a 12-month low-energy liquid diet treatment and maintenance programme for sever obesity. Br J Gen Pract. 2013;63(607):e115-24. doi: 10.3399/bjgp13X663073.
22. Rehackova L, Arnott B, Araujo-Soares V, Adamson A., Taylor R, Sniehotta FF. Efficacy and acceptability of Very Low Energy Diets in overweight and obese people with Type 2 diabetes mellitus: a systematic review with meta-analyses. Diabet. Med. 2015. doi: 10.1111/dme.13005
23. Steven S, Taylor, R. Restoring normoglycaemia by use of a very low calorie diet in long- and short-duration Type 2 diabetes. Diabet Med. 2015. doi: 10.1111/dme.12722
24. Food Standards Agency. The eatwell plate. 2010. http://food.gov.uk/healthiereating/eatwellplate/
25. Catenacci VA, Ogden LG, Stuht J, Phelan S, Wing RR, Hill JO. Physical Activity Patterns in the National Weight Control Registry. Obesity (Silver Spring). 2008;16(1):153-61. doi: 10.1038/oby.2007.6.
26. Tudor-Locke C, Craig CL, Brown WJ, Clemes SA, De Cocker K, Giles-Corti B, et al. How Many Steps/day are Enough? For Adults. Int J Behav Nutr Phys Act. 2011;8:79. http://www.ijbnpa.org/content/8/1/79.
27. Al-Shayji I, Gill J, Cooney J, Siddiqui S, Caslake M. Development of a novel method to determine very low density lipoprotein kinetics. J Lipid Res. 2007;48:2086-95.
28. Blond E, Maitrepierre C, Normand S, Sothier M, Roth H, Goudable J, et al. A new indirect calorimeter is accurate and reliable for measuring basal energy expenditure, thermic effect of food and substrate oxidation in obese and healthy subjects. Eur e-J Clin Nutr Metab. 2011;6:e7ee15.
29. Francis JJ, Johnston M, Robertson C, Glidewell L, Entwistle V, Eccles MP, et al. What is an adequate sample size? Operationalising data saturation for theory-based interview studies. Psychol. Health. 2010;25(10). http://www.tandfonline.com/doi/abs/10.1080/08870440903194015
30. Penn L, Dombrowski SU, Sniehotta FF, White M. Participants' perspectives on making and maintaining behavioural changes in a lifestyle intervention for type 2 diabetes prevention: a qualitative study using the theory domain framework. BMJ Open. 2013;28:3(6). doi: 10.1136/bmjopen-2013-002949. http://www.ncbi.nlm.nih.gov/pubmed/23811173
31. Nwaneri C, Bowen-Jones D, Cooper H, Chikkaveerappa K, Afolabi BA. Falling mortality rates in Type 2 diabetes mellitus in the Wirral Peninsula: a longitudinal and retrospective cohort population-based study. Postgrad Med J. 2012;88(1046):679-83. doi: 10.1136/postgradmedj-2012-130877. Epub 2012 Aug 17.
32. Emerging Risk Factors Collaboration. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015;314(1):52-60. doi: 10.1001/jama.2015.7008.
33. Hex N, Bartlett C, Wright D, Taylor M, Varley D. Estimating the current and future costs of Type 1 and Type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs. Diabet Med. 2012;29(7):855-62. doi: 10.1111/j.1464-5491.2012.03698.x.
34. Diabetes Prevention Programme Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393-403.