Type 2 diabetes mellitus remitted without medication in 46% of subjects who followed a strict, calorie-controlled diet for 1 year, judging from the findings of an open-label, cluster-randomized trial.
Remission rates closely tracked weight loss, Michael E.J. Lean, MD, reported in the Dec. 5 online issue of the Lancet. Among those who lost 15 kg or more, 86% also normalized their hemoglobin A1c levels. Lesser weight losses were successful too, with diabetes remitting in 57% of those who lost 10-15 kg and 34% of those who lost 5-10 kg, reported Dr. Lean, who is chair of human nutrition at the University of Glasgow.
Weight loss conferred other benefits as well. Quality of life improved significantly, triglycerides declined, and about half of the subjects were able to discontinue both their antidiabetic and antihypertension prescriptions.
DiRECT (the Diabetes Remission Clinical Trial) didn’t include a strict exercise component – something that sets it apart from most dietary interventions, Dr. Lean noted in a press statement. Instead, the study’s “Counterweight-plus” diet intervention focused on very strict calorie control. Counterweight is a proprietary, subscription-based weight-loss program that costs about $570 for 1 year.
The paper offered few details about the intervention, which was supervised by a nurse and/or dietitian. For the first 3-5 months, patients consumed only Counterweight-branded soups and shakes, amounting to about 850 calories per day. After that, solid foods were reintroduced over 2-8 weeks. There was ongoing support for weight-loss maintenance, including cognitive-behavioral therapy, combined with strategies to increase physical activity. Activity strategies were confined to encouraging subjects to walk up to 15,000 steps per day in the second and third phase, but the investigators had little hope that this would actually occur.
“It was recognized that this target was unlikely to be achieved by many, and objectively measured physical activity showed no increase in physical activity in either group between baseline and 12 months, which underlines the difficulty this population has in maintaining increased activity,” they noted.
DiRECT enrolled 298 adults with type 2 diabetes recruited from 49 primary care practices across Scotland and England. They were about 54 years old, with a mean diabetes duration of about 3 years. Subjects were assigned to either the Counterweight-plus weight management program or best practice care under current guidelines. At baseline, subjects’ mean body mass index was 35 mg/m2. Their mean HbA1c was about 7.6%; about 75% were taking at least one antidiabetic medication, and 30% taking two or more. Hypertension was present in more than half.
In the active group, investigators withdrew all antidiabetic and antihypertensive medications when the diet commenced. Antihypertensives were restarted only if subjects experienced an increase in systolic blood pressure. Patients in the control group stayed on their medications.
At 12 months, the mean weight loss was significantly greater in the intervention group than the control group (10 kg vs. 1 kg). Weight loss of at least 15 kg occurred in 24% of the intervention group and none of the control group. It was most pronounced in the total diet replacement phase, falling by a mean of 14.5 kg; participants regained weigh during the food reintroduction phase (mean, 1 kg) and again during the maintenance phase (mean, 1.9 kg). Four subjects in the intervention group who experienced diabetes remission needed a “short rescue plan” on the total diet replacement phase because of weight regain within 60 days of the study’s end. The authors didn’t say how much weight these patients regained.
By the end of the study period, diabetes had remitted in 46% of the intervention group and 4% of the control group (odds ratio, 19.7) and was positively associated with the amount of weight loss.
At 12 months, 74% of the intervention group and 18% of the control group were off antidiabetic medications. HbA1c was significantly better in the intervention group (mean 6.4% vs. 7.2%). Antihypertensive drugs also were less common among the intervention group (32% vs. 61%) at 12 months. Despite the reduction in medication, there were no significant changes in blood pressure from baseline.
Nine serious adverse events occurred among seven intervention subjects. Two (biliary colic and abdominal pain) occurred in the same subject and were considered related to the diet, but they did not withdraw promptly.
Counterweight sponsored the trial, and several of the coinvestigators are stockholders and were company employees during the study. Dr. Lean reported financial remuneration from Counterweight.
SOURCE: Lean M et al. Lancet 2017 Dec 5; doi: 10.1016/ S0140-6736(17)33102-1.