Status:
COMPLETED
The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Conditions:
Obesity
Impaired Glucose Tolerance
Eligibility:
FEMALE
25-60 years
Phase:
PHASE4
Brief Summary
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 witho...
Detailed Description
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 pop...
Eligibility Criteria
Inclusion
- Females aged 25-60
- BMI 28-35 kg/m2
- No known diagnosis of diabetes
- No known diagnosis of coronary heart disease
- Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week)
- Stable weight (variation \< 3 kg within 6 months of screening visit)
- Ability to give informed consent
- Ability to follow verbal and written instructions
- Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
- Nonsmoker (tobacco, marijuana)
- Outpatient visits every 2 weeks throughout the study period are required. While most of these visits are short (15 minutes)ability to commute to the performance site in Boston, on a regular basis, is necessary.
Exclusion
- Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
- Coronary heart disease (history of myocardial infarction or unstable angina pectoris)
- Uncontrolled hypertension hypertension (BP \> 150/90 mmHg on or off antihypertensive medication)
- Uncontrolled dyslipidemia (LDL \> 200 or TG \> 400 on or off lipid lowering medication)
- Tobacco, marijuana or intravenous drug use
- Shift workers (night shift or alternating day/night shifts)
- Recent weight loss (\> 3 kg within 4 months of the screening visit)
- Gastroparesis
- Inflammatory bowel disease
- Malignancy treated with chemotherapy within the past 3 years
- History of pancreatitis
- Depression requiring hospitalization or diagnosis of psychosis
- Renal insufficiency (creatinine clearance \< 50 ml/min)
- Transaminases \> 2x above the normal range
- Pregnancy within 6 months of the screening visit
- Breastfeeding
- Failure to use medically approved contraceptive methods
- History of an eating disorder (anorexia, bulimia or laxative abuse)
- History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
- New diagnosis of hypo or hyperthyroidism within 1 year of screening visit
- Previous participation in a clinical study with exenatide
- Presence or history of allergic reaction to multiple drugs
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00456885
Start Date
April 1 2007
End Date
September 1 2010
Last Update
September 11 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215