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

NCT ID: NCT00456885

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-09-30

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 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.

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 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.

Conditions

Obesity; Impaired Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exenatide First

Started on Exenatide, 3 week washout, start placebo

Group Type: PLACEBO_COMPARATOR

exenatide

Intervention Type: DRUG

5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks

Placebo

Intervention Type: DRUG

Twice daily injection of placebo

Placebo First

Started on placebo, 3 week washout, start exenatide

Group Type: EXPERIMENTAL

exenatide

Intervention Type: DRUG

5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks

Placebo

Intervention Type: DRUG

Twice daily injection of placebo

Interventions

exenatide

5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks

Intervention Type: DRUG

Placebo

Twice daily injection of placebo

Intervention Type: DRUG

Other Intervention Names

Byetta

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Amylin Pharmaceuticals, LLC.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eleftheria Maratos-Flier

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eleftheria Maratos-Flier, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Dushay J, Gao C, Gopalakrishnan GS, Crawley M, Mitten EK, Wilker E, Mullington J, Maratos-Flier E. Short-term exenatide treatment leads to significant weight loss in a subset of obese women without diabetes. Diabetes Care. 2012 Jan;35(1):4-11. doi: 10.2337/dc11-0931. Epub 2011 Oct 31.

Reference Type: RESULT

PMID: 22040840 (View on PubMed)

Other Identifiers

BFA912

Identifier Type: -

Identifier Source: secondary_id

2006P000361

Identifier Type: -

Identifier Source: org_study_id