Louise McCombie

Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial

BACKGROUND Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes. METHODS We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20-65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27-45 kg/m2, and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825-853 kcal/day formula diet for 3-5 months), stepped food reintroduction (2-8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA1c) of less than 6·5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. These outcomes were analysed hierarchically. This trial is registered with the ISRCTN registry, number 03267836. FINDINGS Between July 25, 2014, and Aug 5, 2017, we recruited 306 individuals from 49 intervention (n=23) and control (n=26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, we recorded weight loss of 15 kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0·0001). Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19·7, 95% CI 7·8-49·8; p<0·0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, six (7%) of 89 participants who maintained 0-5 kg weight loss, 19 (34%) of 56 participants with 5-10 kg loss, 16 (57%) of 28 participants with 10-15 kg loss, and 31 (86%) of 36 participants who lost 15 kg or more. Mean bodyweight fell by 10·0 kg (SD 8·0) in the intervention group and 1·0 kg (3·7) in the control group (adjusted difference -8·8 kg, 95% CI -10·3 to -7·3; p<0·0001). Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7·2 points (SD 21·3) in the intervention group, and decreased by 2·9 points (15·5) in the control group (adjusted difference 6·4 points, 95% CI 2·5-10·3; p=0·0012). Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, were deemed potentially related to the intervention. No serious adverse events led to withdrawal from the study. INTERPRETATION Our findings show that, at 12 months, almost half of participants achieved remission to a non-diabetic state and off antidiabetic drugs. Remission of type 2 diabetes is a practical target for primary care. FUNDING Diabetes UK.

Feasibility and indicative results from a 12-month low-energy liquid diet treatment and maintenance programme for severe obesity

BACKGROUND There is no established primary care solution for the rapidly increasing numbers of severely obese people with body mass index (BMI) > 40 kg/m(2). AIM This programme aimed to generate weight losses of ≥15 kg at 12 months, within routine primary care. DESIGN AND SETTING Feasibility study in primary care. METHOD Patients with a BMI ≥40 kg/m(2) commenced a micronutrient-replete 810-833 kcal/day low-energy liquid diet (LELD), delivered in primary care, for a planned 12 weeks or 20 kg weight loss (whichever was the sooner), with structured food reintroduction and then weight-loss maintenance, with optional orlistat to 12 months. RESULT Of 91 patients (74 females) entering the programme (baseline: weight 131 kg, BMI 48 kg/m(2), age 46 years), 58/91(64%) completed the LELD stage, with a mean duration of 14.4 weeks (standard deviation [SD] = 6.0 weeks), and a mean weight loss of 16.9 kg (SD = 6.0 kg). Four patients commenced weight-loss maintenance omitting the food-reintroduction stage. Of the remaining 54, 37(68%) started and completed food reintroduction over a mean duration of 9.3 weeks (SD = 5.7 weeks), with a further mean weight loss of 2.1 kg (SD = 3.7 kg), before starting a long-term low-fat-diet weight-loss maintenance plan. A total of 44/91 (48%) received orlistat at some stage. At 12 months, weight was recorded for 68/91 (75%) patients, with a mean loss of 12.4 kg (SD = 11.4 kg). Of these, 30 (33% of all 91 patients starting the programme) had a documented maintained weight loss of ≥15 kg at 12 months, six (7%) had a 10-15 kg loss, and 11 (12%) had a 5-10 kg loss. The indicative cost of providing this entire programme for wider implementation would be £861 per patient entered, or £2611 per documented 15 kg loss achieved. CONCLUSION A care package within routine primary care for severe obesity, including LELD, food reintroduction, and weight-loss maintenance, was well accepted and achieved a 12-month-maintained weight loss of ≥15 kg for one-third of all patients entering the programme.

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.

Beating type 2 diabetes into remission

Recognising and accurately coding reversal of type 2 diabetes is key to improving outcomes and reducing healthcare costs, argue Louise McCombie and colleagues

Weight management in adults

To understand the needs of individuals with intellectual disabilities (IDs), this chapter will start with a definition of ID, a summary of the prevalence studies of obesity and an outline of the determinants of obesity in this population group. National clinical guidelines [1–2] recommend the use of multicomponent weight loss interventions for the management of obesity. Therefore, the issues around multicomponent weight loss interventions for adults with ID and obesity are discussed in the final part of the chapter.