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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00456885
First Posted: April 5, 2007
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
Eleftheria Maratos-Flier, Beth Israel Deaconess Medical Center
  Purpose

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.


Condition Intervention Phase
Obesity Impaired Glucose Tolerance Drug: exenatide Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eleftheria Maratos-Flier, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Change in Weight [ Time Frame: 16 weeks after the beginning of each treatment ]
    Change in weight at the end of each treatment period.

  • Change in Body Mass Index [ Time Frame: 16 weeks from the start of each treatment period. ]

Secondary Outcome Measures:
  • Change in Waist Circumference [ Time Frame: 16 weeks from the start of each treatment period. ]
  • Systolic Blood Pressure [ Time Frame: 16 weeks after the beginning of each treatment ]
    Blood pressure was measured using a Dynamap automated monitoring device. The change is reported as the blood pressure measured at the beginning of the treatment group and after 16 weeks. We are reporting the change in the systolic blood presssure recorded.

  • Changes in Body Composition [ Time Frame: 16 weeks after the beginning of each treatment ]
    Per cent body body fat was assessed using bio-electrical impedance with a BIA; RJL System Quantum II Bioelectrical Body Composition Analyzer. The data is reported as per cent body fat.

  • Changes in Leptin [ Time Frame: 16 weeks from the start of each treatment period. ]
  • Diastolic Blood Pressure [ Time Frame: 16 weeks after the beginning of each treatment ]
  • Adiponectin [ Time Frame: 16 weeks after the beginning of each treatment ]
  • Change in Insulin [ Time Frame: 16 weeks from the start of each treatment period. ]
  • Change in Fasting Glucose [ Time Frame: 16 weeks from the start of each treatment period. ]
  • Change in Two Hour Glucose [ Time Frame: 16 weeks from the start of each treatment period. ]
  • HOMA Score [ Time Frame: 16 weeks from the start of each treatment period. ]
  • REE [ Time Frame: 16 weeks from the start of each treatment period. ]
    Resting Energy Expenditure


Enrollment: 41
Study Start Date: April 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Exenatide First
Started on Exenatide, 3 week washout, start placebo
Drug: exenatide
5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks
Other Name: Byetta
Drug: Placebo
Twice daily injection of placebo
Experimental: Placebo First
Started on placebo, 3 week washout, start exenatide
Drug: exenatide
5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks
Other Name: Byetta
Drug: Placebo
Twice daily injection of placebo

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456885


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Principal Investigator: Eleftheria Maratos-Flier, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Eleftheria Maratos-Flier, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00456885     History of Changes
Other Study ID Numbers: 2006P000361
BFA912
First Submitted: April 4, 2007
First Posted: April 5, 2007
Results First Submitted: March 30, 2017
Results First Posted: September 11, 2017
Last Update Posted: September 11, 2017
Last Verified: August 2017

Keywords provided by Eleftheria Maratos-Flier, Beth Israel Deaconess Medical Center:
obesity
double blind
placebo controlled
weight loss
appetite
energy expenditure

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists