The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women

Obesity Clinical Trial

Official title:

The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456885
• Other study ID #: 2006-p-000361
• Secondary ID: BFA912
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2007
• Last updated: February 24, 2012
• Start date: April 2007
• Est. completion date: September 2010

Study information

• Verified date: February 2012
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance
• Obesity

Intervention

Drug:
• exenatide
5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Amylin Pharmaceuticals, LLC., Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		37 Weeks	No
Secondary	Changes in resting and total energy expenditure		37 Weeks	No
Secondary	Changes in sleep patterns		37 Weeks	No
Secondary	Changes in hunger, satiety and nausea		37 Weeks	No
Secondary	Changes in food intake		37 Weeks	No
Secondary	Changes in metabolic parameters		37 Weeks	No
Secondary	Changes in body composition		37 Weeks	No
Secondary	Changes in inflammatory markers		37 Weeks	No