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OBJECTIVE- To assess the effects of exenatide on body weight and glucose tolerance in nondiabetic obese subjects with normal or impaired glucose tolerance (IGT) or impaired fasting glucose (IFG).
RESEARCH DESIGN AND METHODS- Obese subjects (n = 152; age 46 ± 12 years, female 82%, weight 108.6 ± 23.0 kg, BMI 39.6 ± 7.0 kg/m^sup 2^, IGT or IFG 25%) were randomized to receive exenatide (n = 73) or placebo (n = 79), along with lifestyle intervention, for 24 weeks.
RESULTS- Exenatide-treated subjects lost 5.1 ± 0.5 kg from baseline versus 1.6 ± 0.5 kg with placebo (exenatide - placebo, P < 0.001). Placebo-subtracted difference in percent weight reduction was -3.3 ± 0.5% (P < 0.001). Both groups reduced their daily calorie intake (exenatide, -449 cal; placebo, -387 cal). IGT or IFG normalized at end point in 77 and 56% of exenatide and placebo subjects, respectively.
CONCLUSIONS- Exenatide plus lifestyle modification decreased caloric intake and resulted in weight loss in nondiabetic obesity with improved glucose tolerance in subjects with IGT and IFG.
Diabetes Care 33:1173-1175, 2010
Several well-designed trials have demonstrated that weight reduction can reduce diabetes risk (1-4). However, with only lifestyle modification, even modest weight loss is difficult to achieve over time (5,6); therefore, optimal pharmacologie strategies for treating obesity are being developed. This study explored exenatide in combination with lifestyle modification as treatment for weight loss in nondiabetic obese subjects with normal glucose tolerance (NGT), impaired glucose tolerance (IGT), or impaired fasting glucose (IFG).
RESEARCH DESIGN AND METHODS- Obese adult subjects with a BMI ^3O kg/m2 were included. Subjects with type 2 diabetes, previous use of glucose -lowering medications for >3 months, or unstable body weight before screening were excluded. At screening, subjects received an oral glucose tolerance test to stratify into subgroups: NGT, IGT (fasting glucose <7 mmol/1 and 2-h postprandial glucose ^7.8 and <11.1 mmol/1), or IFG (fasting glucose 6.1-6.9 mmol/1 and 2-h postprandial glucose <7.8 mmol/1). Subjects then participated in a 1-week single -blind placebo lead-in period before randomization to exenatide (10 µg with a 4-week 5^g dose-initiation period) or placebo administered before morning and evening meals. A structured program of diet and physical activity was implemented through week 24. Subjects fasted overnight, and study drug was withheld...