Predictors of type 2 diabetes remission in the Diabetes Remission Clinical Trial (DiRECT).

AIM: To identify predictors of type 2 diabetes remission in the intervention arm of DiRECT (Diabetes Remission Clinical Trial). METHODS: Participants were aged 20-65 years, with type 2 diabetes duration of <6 years and BMI 27-45 kg/m2 , and were not receiving insulin. Weight loss was initiated by total diet replacement (825-853 kcal/day, 3-5 months, shakes/soups), and weight loss maintenance support was provided for 2 years. Remissions (HbA1c <48 mmol/mol [<6.5%], without antidiabetes medications) in the intervention group (n = 149, mean age 53 years, BMI 35 kg/m2 ) were achieved by 68/149 participants (46%) at 12 months and by 53/149 participants (36%) at 24 months. Potential predictors were examined by logistic regression analyses, with adjustments for weight loss and effects independent of weight loss. RESULTS: Baseline predictors of remission at 12 and 24 months included being prescribed fewer antidiabetes medications, having lower triglyceride and gamma-glutamyl transferase levels, and reporting better quality of life with less anxiety/depression. Lower baseline HbA1c was a predictor at 12 months, and older age and male sex were predictors at 24 months. Being prescribed antidepressants predicted non-remission. Some, but not all effects were explained by weight loss. Weight loss was the strongest predictor of remission at 12 months (adjusted odds ratio per kg weight loss 1.24, 95% CI 1.14, 1.34; P < 0.0001) and 24 months (adjusted odds ratio 1.23, 95% CI 1.13, 1.35; P <0.0001). Weight loss in kilograms and percentage weight loss were equally good predictors. Early weight loss and higher programme attendance predicted more remissions. Baseline BMI, fasting insulin, fasting C-peptide and diabetes duration did not predict remission. CONCLUSIONS: Other than weight loss, most predictors were modest, and not sufficient to identify subgroups for which remission was not a worthwhile target.

Type 2 diabetes remission: economic evaluation of the DiRECT/Counterweight-Plus weight management programme within a primary care randomized controlled trial.

AIM: The Counterweight-Plus weight management programme achieved 46% remission of Type 2 diabetes at 1 year in the DiRECT trial. We estimated the implementation costs of the Counterweight-Plus programme and its 1-year cost-effectiveness in terms of diabetes remission, compared with usual care, from the UK National Health Service (NHS) perspective. METHODS: Within-trial total costs included programme set-up and running costs (practitioner appointment visits, low-energy formula diet sachets and training), oral anti-diabetes and anti-hypertensive medications, and healthcare contacts. Total costs were calculated for aggregated resource use for each participant and 95% confidence intervals (CI) were based on 1000 non-parametric bootstrap iterations. RESULTS: One-year programme costs under trial conditions were estimated at £1137 per participant (95% CI £1071, £1205). The intervention led to a significant cost-saving of £120 (95% CI £78, £163) for the oral anti-diabetes drugs and £14 (95% CI £7.9, £22) for anti-hypertensive medications compared with the control. Deducting the cost-savings of all healthcare contacts from the intervention cost resulted an incremental cost of £982 (95% CI £732, £1258). Cost per 1 year of diabetes remission was £2359 (95% CI £1668, £3250). CONCLUSIONS: Remission of Type 2 diabetes within 1-year can be achieved at a cost below the annual cost of diabetes (including complications). Providing a reasonable proportion of remissions can be maintained over time, with multiple medical gains expected, as well as immediate social benefits, there is a case for shifting resources within diabetes care budgets to offer support for people with Type 2 diabetes to attempt remission. (Clinical Trial Registry No.: ISRCTN03267836).

Filling the intervention gap: service evaluation of an intensive nonsurgical weight management programme for severe and complex obesity.

BACKGROUND: Weight management including formula total diet replacement (TDR) is emerging as an effective intervention for severe and complex obesity, particularly with respect to type 2 diabetes (T2DM). However, no prospective audit and service evaluation of such programmes have been reported. METHODS: Following initial feasibility piloting, the Counterweight-Plus programme was commissioned across a variety of healthcare providers. The programme includes: Screening, TDR (formula low energy diet), food reintroduction and weight loss maintenance, all delivered by staff with 8 h of training, in-service mentoring, ongoing specialist support and access to medical consultant expertise. Anonymised data are returned centrally for clinical evaluation. RESULTS: Up to December 2016, 288 patients commenced the programme. Mean (SD) baseline characteristics were: age 47.5 (12.7) years, weight 128.0 (32.0) kg, body mass index 45.7 (10.1) kg m-2 , n = 76 (26.5%) were male and n = 99 (34.5%) had T2DM. On an intention-to-treat (ITT) basis, a loss of ≥15 kg at 12 months was achieved by 48 patients, representing 22.1% of all who started and 40% of those who maintained engagement. For complete cases, mean (95% confidence interval) weight loss was 13.3 (12.1-14.4) kg at 3 months, 16.0 (14.4-17.6) kg at 6 months and 14.2 (12.1-16.3) kg at 12 months (all P < 0.001), with losses to follow-up of 10.8%, 29.3% and 44.2%, respectively. Mean loss at 12 months by ITT analyses was: single imputation -10.5 (9.5) kg, last observation carried forward -10.9 (11.6) kg and baseline observation carried forward -7.9 (11.1) kg. The presence of diabetes had no significant impact on weight change outcomes. CONCLUSIONS: This nonsurgical approach is effective for many individuals with severe and complex obesity, representing an option before considering surgery. The results are equally effective in terms of weight loss for people with T2DM.

Effective UK weight management services for adults.

A number of evidence-based weight management interventions are now available with different models and serving different patient/client groups. While positive outcomes are a key to the decision-making process, so too is the information around how these outcomes were achieved, in what population, how transferable the outcomes would be to the population a service would be aiming to cover and at what cost to the service provider and or the individual. This paper examines all the UK interventions with recent peer-reviewed evidence of their effectiveness in 'realistic' settings and cost-effectiveness, in the context of National Institute of Health and Clinical Excellence (NICE) and Scottish Intercollegiate Guideline Network (SIGN) guidelines. It concludes that the evidence-based approaches allow intervention at different stages in the disease process of obesity, which are effective in different settings. Self-referral to commercial agencies, by individuals with relatively low body mass index (BMI) and few medical complications, is a reasonable first step. For more severely obese individuals (e.g. BMI > 35 kg m(-2) ) requiring more medically complicated care, evidence is largely lacking for these services, but the community-based Counterweight Programme is effective and cost-effective in maintaining weight loss >5 kg up to 2 years for 30-40% of attenders. For more complicated and resistant obesity, referral to a secondary care-based service can generate short-term weight loss, but 12-month data are unavailable.

Weight management: a survey of current practice in secondary care NHS settings in 2004.

OBJECTIVE: To determine the current practices in relation to weight management currently provided for overweight/obese patients attending different secondary care outpatient clinics. METHODS: Postal questionnaire sent to 100 consultant clinicians working in a range of specialist areas in three NHS Trust areas in Scotland, between January and March 2004. RESULTS: Overall response rate was 55%. Only 9% (five) of clinicians reported having a protocol in place for the management of patients who were overweight or obese. Lack of expertise and inaccessibility to expertise were cited frequently as reasons for having no protocol in place. Fifty-one per cent felt that weight management (including obesity treatment) should be undertaken by a specialist service either run by general practitioners (GPs), or by clinicians in a secondary care setting. Around a third of all those surveyed reported willingness to incorporate obesity management within their own routine specialty practice. CONCLUSION: Clinicians acknowledged the adverse health effects of obesity within their specialist area, but felt unskilled and under-resourced to provide effective management. Effective prevention and management are required to challenge the obesity epidemic and will require the involvement of both primary and secondary care NHS settings. It is encouraging that a third of respondents felt prepared to incorporate obesity and weight management within their routine specialist practice.

Nutritional support for patients with intellectual disability and nutrition/dysphagia disorders in community care.

Patients with intellectual disability and neurological handicaps associated with swallowing difficulties are vulnerable to dehydration and undernutrition. Some patients are severely undernourished, a condition which is usually associated with recurrent food aspiration and respiratory infections. Underweight patients are usually provided with adequate dietary protein by carers: their low energy intakes reflect inadequate intakes of fat and carbohydrate. Many patients gain weight following the provision of easily assimilated energy-dense fat- and sugar-containing foods. Where these measures fail, the provision of a percutaneous endoscopic gastrostomy (PEG) tube may be life-saving. Optimal supervision of patients with severe nutrition/dysphagia problems requires a support network linking carers at home or in community care facilities with the primary health care team and the local district general hospital.