Lean MEJ, et al. - Researchers attempted to ascertain if intensive weight management within routine primary care would achieve remission of type 2 diabetes. It was determined that nearly half of the enrollees achieved remission to a non-diabetic state and off antidiabetic drugs at 12 months. Hence, remission of type 2 diabetes presented as a practical target for primary care.

Methods

• This open-label, cluster-randomised trial (DiRECT) was performed at 49 primary care practices in Scotland and the Tyneside region of England.
• Practices were randomly assigned (1:1), via a computer-generated list.
• The intention was 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 this allocation.
• Nonetheless, it was hidden from the study statistician.
• The eligible candidates included patients 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 constituted 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.
• 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 were included as the co-primary outcomes, which were evaluated hierarchically.

Results

• A total of 306 individuals were recruited from 49 intervention (n=23) and control (n=26) general practices, between July 25, 2014, and Aug 5, 2017.
• Among these, 149 participants per group consisted of the intention-to-treat population.
• At 12 months, weight loss of 15 kg or more were recorded in 36 (24%) enrollees belonging to the intervention group and no participants in the control group (p < 0·0001).
• In 68 (46%) participants of the intervention group and six (4%) participants in the control group (odds ratio 19·7, 95% CI 7·8-49·8; p < 0·0001) diabetes remission was achieved.
• Variation was reported in the remission with weight loss in the study cohort, 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 subjects with 5-10 kg loss, 16 (57%) of 28 individuals with 10-15 kg loss, and 31 (86%) of 36 candidates who lost 15 kg or more.
• It was noted that the 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).
• As estimated via the EuroQol 5 Dimensions visual analogue scale, an improvement was found in the quality of life, 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).
• The findings disclosed 9 serious adverse events by 7 (4%) of 157 enrollees in the intervention group and 2 by two (1%) subjects in the control group.
• Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, appeared to be possibly associated with the intervention.
• Withdrawal due to serious adverse events was not reported.