The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
Condition: Obesity; Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Intervention: exenatide; Placebo
Intervention description: 5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks; Twice daily injection of placebo
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: Female
Minimum age: 25 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: obesity; double blind; placebo controlled; weight loss; appetite; energy expenditure

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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Females aged 25-60

          2. BMI 28-35 kg/m2

          3. No known diagnosis of diabetes

          4. No known diagnosis of coronary heart disease

          5. Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no
             more than 1 hour per week)

          6. Stable weight (variation < 3 kg within 6 months of screening visit)

          7. Ability to give informed consent

          8. Ability to follow verbal and written instructions

          9. Use of medically approved form of contraception (monophasic oral contraception, intra
             uterine device, surgical sterilization or 2 combined barrier methods)

         10. Nonsmoker (tobacco, marijuana)

         11. 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 Criteria:

          1. Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes
             Association criteria

          2. Coronary heart disease (history of myocardial infarction or unstable angina pectoris)

          3. Uncontrolled hypertension hypertension (BP > 150/90 mmHg on or off antihypertensive
             medication)

          4. Uncontrolled dyslipidemia (LDL > 200 or TG > 400 on or off lipid lowering medication)

          5. Tobacco, marijuana or intravenous drug use

          6. Shift workers (night shift or alternating day/night shifts)

          7. Recent weight loss (> 3 kg within 4 months of the screening visit)

          8. Gastroparesis

          9. Inflammatory bowel disease

         10. Malignancy treated with chemotherapy within the past 3 years

         11. History of pancreatitis

         12. Depression requiring hospitalization or diagnosis of psychosis

         13. Renal insufficiency (creatinine clearance < 50 ml/min)

         14. Transaminases > 2x above the normal range

         15. Pregnancy within 6 months of the screening visit

         16. Breastfeeding

         17. Failure to use medically approved contraceptive methods

         18. History of an eating disorder (anorexia, bulimia or laxative abuse)

         19. History of surgery for the treatment of obesity (gastric banding, gastric bypass,
             gastric stapling)

         20. New diagnosis of hypo or hyperthyroidism within 1 year of screening visit

         21. Previous participation in a clinical study with exenatide

         22. Presence or history of allergic reaction to multiple drugs