Weight change in the management of youth-onset type 2 diabetes: the TODAY clinical trial experience.

BACKGROUND: The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial documented that metformin plus rosiglitazone, but not metformin plus lifestyle intervention, provided superior durability of glycemic control relative to metformin monotherapy. OBJECTIVES: We examined weight changes among TODAY participants that completed at least 6 months of treatment, evaluated predictors of lifestyle outcome, and examined whether weight changes were related to cardiometabolic outcomes across treatment arms. METHODS: The 595 youth with type 2 diabetes, (85.1% of randomized participants aged 11-17 years) completed assessments of weight-related and cardiometabolic measures at months 0, 6, 12 and 24. Repeated measures models were used to investigate associations over time. RESULTS: Lifestyle intervention did not enhance outcome relative to metformin alone and no predictors of response to lifestyle treatment were identified. However, changes in percent overweight across treatment arms were associated with changes in multiple cardiometabolic risk factors, and decreases of ≥ 7% in overweight were associated with significant benefits over 24 months. CONCLUSIONS: Although adjunctive intensive lifestyle intervention did not improve weight-related outcomes, weight changes in the full TODAY sample were associated with small, but significant improvements in cardiometabolic status, highlighting the importance of optimizing weight management in youth with T2DM.

Effects of a very-low-calorie diet on long-term glycemic control in obese type 2 diabetic subjects.

We tested the hypothesis that the use of a very-low-calorie diet (VLCD) in combination with behavior modification would promote long-term glycemic control in obese type 2 diabetic subjects. Thirty-six diabetic subjects were randomly assigned to a standard behavior therapy program or to a behavior therapy program that included an 8-week period of VLCD. The behavior therapy group consumed a balanced diet of 4200 to 6300 J/d throughout the 20-week program. The VLCD group consumed a balanced diet of 4200 to 6300 J for weeks 1 to 4, followed by a VLCD (1680 J/d of lean meat, fish, and fowl) for weeks 5 to 12. The VLCD group then gradually reintroduced other foods during weeks 13 to 16 and consumed a balanced diet of 4200 to 6300 J/d for weeks 17 to 20. Thirty-three of the 36 subjects completed the 20-week program and the 1-year follow-up. Use of the VLCD produced greater decreases in fasting glucose at the end of the 20-week program and at 1-year follow-up and greater long-term reductions in HbA1. The VLCD group also had greater weight losses at week 20, but weight losses from pretreatment to 1-year follow-up were similar in the two treatment groups. The improved glycemic control with the VLCD appeared to be due to increased insulin secretion, but further research is needed to confirm this.

A double-blind, placebo-controlled trial of fluoxetine plus behavior modification in the treatment of obese binge-eaters and non-binge-eaters.

To determine whether fluoxetine is effective in the long-term treatment of obesity and whether it is particularly useful in the treatment of obese binge-eaters, the authors randomly assigned 45 obese subjects (22 with binge-eating problems and 23 without binge-eating) to fluoxetine (60 mg/day) or placebo in a 52-week double-blind trial. The 21 subjects who completed the trial made 13 clinic visits and were taught basic behavior modification strategies. Patients treated with fluoxetine plus behavior modification lost significantly more weight than those treated with placebo plus behavior modification. However, the drug did not appear to have a differential benefit for binge-eaters.

Variables associated with weight loss and improvements in glycemic control in type II diabetic patients in behavioral weight control programs.

Because weight loss is difficult to achieve, it would be helpful to determine whether there are subgroups of obese type II diabetic patients who benefit most from participation in a behavioral weight loss program. We studied 178 obese patients with type II diabetes, who participated in a 12-20 week behavioral weight loss program and were followed for 1 year after the program to determine whether age, gender, percent overweight, medication, duration of diabetes or fasting glucose were related to weight loss and/or to the magnitude of improvement in glycemic control experienced with weight loss. Gender was the only variable related to weight loss; males lost more weight and had greater decreases in percent overweight than females. The variable most strongly related to improvement in glycemic control was pretreatment fasting glucose level; patients with higher initial glucose levels experienced the greatest improvements in control. There was no evidence to support the belief that patients on insulin have poorer weight losses or that patients with long-duration diabetes benefit less from weight reduction than those with recent-onset diabetes.