The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
This study will look at the effect of exenatide, a drug which has been approved for the treatment of type 2 diabetes, on body weight, appetite and energy expenditure among moderately obese women without diabetes.
The study is 35 weeks long and includes 19 outpatient visits. Participants will receive exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between. Neither participants nor investigators will know whether exenatide or placebo is being administered. Participants will be started randomly on either exenatide or placebo.
Our hypothesis is that treatment with exenatide will curb appetite and lead to weight loss and may lead to changes in energy expenditure.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus|
- weight loss [ Time Frame: 37 Weeks ] [ Designated as safety issue: No ]
- Changes in resting and total energy expenditure [ Time Frame: 37 Weeks ] [ Designated as safety issue: No ]
- Changes in sleep patterns [ Time Frame: 37 Weeks ] [ Designated as safety issue: No ]
- Changes in hunger, satiety and nausea [ Time Frame: 37 Weeks ] [ Designated as safety issue: No ]
- Changes in food intake [ Time Frame: 37 Weeks ] [ Designated as safety issue: No ]
- Changes in metabolic parameters [ Time Frame: 37 Weeks ] [ Designated as safety issue: No ]
- Changes in body composition [ Time Frame: 37 Weeks ] [ Designated as safety issue: No ]
- Changes in inflammatory markers [ Time Frame: 37 Weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
This study will examine the effect of exenatide on body weight, energy expenditure, satiety, sleep, and metabolic parameters in healthy, moderately obese women (BMI 28-35 kg/m2). We will look at 2 populations of women, one with normal glucose metabolism and one with impaired glucose homeostasis (IGH)--either impaired fasting glucose (IFG, fasting glucose 101-125 mg/dL) or impaired glucose tolerance (IGT, glucose 140-199 mg/dL 2h after a 75g oral glucose load). This is a randomized, double blind, crossover study with two 16-week treatment periods separated by a 3-week washout period. There are 19 study visits over 35 weeks.
The goals of this study are 1) to examine the effect of exenatide on body weight and dysglycemia in populations in which this medication has not been studied, namely obese women with and without IGH and 2) to investigate possible mechanisms of weight loss through measurements of energy expenditure, hunger, satiety, nausea, and sleep.
The primary outcome of this study is weight loss. We will calculate absolute and relative change in body weight from baseline to week 16 (the first treatment period) and from week 19 to week 35 (the second treatment period). Body weight will be measured at every study visit which will also allow us to assess the absolute and relative change from baseline throughout the entire study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456885
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Eleftheria Maratos-Flier, MD||Beth Israel Deaconess Medical Center|