Diabetes UK.

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence Newcastle University ePrints -eprint.ncl.ac.uk Lean MEJ,

BackgroundDespite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33 % of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion.The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response.Methods/DesignCluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m2. Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥ 15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years.DiscussionThis study will establish whether a structured weight management programme, delivered in Primary Care by practice nurses or dietitians, is a viable treatment to achieve T2DM remission. Results, available from 2018 onwards, will inform future service strategy.Trial registrationCurrent Controlled Trials ISRCTN03267836. Date of Registration 20/12/2013Electronic supplementary materialThe online version of this article (doi:10.1186/s12875-016-0406-2) contains supplementary material, which is available to authorized users.

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Evaluation for obesity management in primary care is limited, and successful outcomes are from intensive clinical trials in hospital settings. AimTo determine to what extent measures of success seen in intensive clinical trials can be achieved in routine primary care. Primary outcome measures were weight change and percentage of patients achieving ≥5% loss at 12 and 24 months. Design of studyProspective evaluation of a new continuous improvement model for weight management in primary care. SettingPrimary care, UK. MethodPrimary care practice nurses from 65 UK general practices delivered interventions to 1906 patients with body mass index (BMI) ≥30 kg/m 2 or ≥28 kg/m 2 with obesity-related comorbidities. ResultsMean baseline weight was 101.2 kg (BMI 37.1 kg/m 2 ); 25% of patients had BMI ≥40 kg/m 2 and 74% had ≥1 major obesity-related comorbidity. At final data capture 1419 patients were in the programme for ≥12 months, and 825 for ≥24 months. Mean weight change in those who attended and had data at 12 months (n = 642) was -3.0 kg (95% CI = -3.5 to -2.4 kg) and at 24 months (n = 357) was -2.3 kg (95% CI = -3.2 to -1.4 kg). Among attenders at specific time-points, 30.7% had maintained weight loss of ≥5% at 12 months, and 31.9% at 24 months. A total of 761 (54%) of all 1419 patients who had been enrolled in the programme for >12 months provided data at or beyond 12 months. ConclusionThis intervention achieves and maintains clinically valuable weight loss within routine primary care.