One-Year Outcome of a Combination of Weight Loss Therapies for Subjects With Type 2 Diabetes

Abstract

OBJECTIVE -The purpose of this study was to evaluate the effects of a combination weight loss program using intermittent low-calorie diets, energy-controlled meal replacement products, and sibutramine on weight loss, diabetes control, and cardiovascular risk factors in overweight or obese subjects with type 2 diabetes.RESEARCH DESIGN AND METHODS -Overweight or obese individuals with type 2 diabetes treated with diet or oral medication were randomly assigned to either a standard therapy or combination therapy group. Both groups received a standardized program to facilitate weight loss. The combination therapy group also received 10 -15 mg sibutramine daily, low-calorie diets using meal replacement products for 1 week every 2 months, and between low-calorie diet weeks, once daily use of meal replacement product and snack bars to replace one usual meal and snack. Primary outcome measures were changes in body weight, glycemic control, plasma lipids, blood pressure, pulse, and body composition at 1 year.RESULTS -At 1 year, combination therapy, compared with standard therapy, resulted in significantly more weight loss (Ϫ7.3 Ϯ 1.3 kg vs. Ϫ0.8 Ϯ 0.9 kg, P Ͻ 0.001) and reduction in HbA 1c (Ϫ0.6 Ϯ 0.3 vs. 0.0 Ϯ 0.2%, P ϭ 0.05). Combination therapy resulted in reduced requirement for diabetes medications and decreased fat mass and lean body mass. A 5-kg decrease in weight at 1 year was associated with a decrease of 0.4% in HbA 1c (P ϭ 0.006). Changes in fasting glucose, lipids, pulse, and blood pressure did not differ between groups.CONCLUSIONS -This combination weight loss program resulted in greater weight loss and improved diabetes control compared with a standard weight loss program in overweight or obese subjects with type 2 diabetes.

Two-Year Outcome of a Combination of Weight Loss Therapies for Type 2 Diabetes

“…As previously reported, the S/C therapy group lost little weight during year 1 of standard therapy (15). After starting combination therapy at the beginning of year 2, this group demonstrated a pattern of weight loss similar to that observed during year 1 in the C therapy group.…”

“…We have previously reported that this combination program for weight loss produced significantly more weight loss and improved diabetes control compared with a standard weight loss program at 1 year (15). We now report that subjects who followed the combination therapy program for 2 years maintained significant weight loss of 4.6 kg and had a decrement in HbA 1c of 0.5%.…”

“…Accordingly, we initiated a clinical trial combining intermittent low-calorie diets, energy-controlled meal replacements, and sibutramine to treat overweight and obese type 2 diabetic subjects. The 1-year results have previously been reported (15). Herein, we report the 2-year results with primary focus on those subjects who received the combination therapy weight loss program throughout the entire 2 years of study.…”

“…Fasting plasma glucose, HbA 1c , fasting plasma total cholesterol, HDL cholesterol, and triglycerides were determined as previously described (15). LDL cholesterol was calculated unless fasting plasma triglycerides exceeded 400 mg/dl.…”

Duodenal Electric Stimulation

“…1 The components of the duodenal pacer BBALANCE system^: left implantable pulse generator (IPG) and bipolar lead with two electrodes; right remote control and laptop Fig. 2 The two BALANCE system leads attached to the duedenum wall [23]. It is therefore likely that further effects of duodenal stimulation are responsible for the metabolic effect.…”