Back to resultsThe Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
Primary Purpose
Obesity, Impaired Glucose Tolerance
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
exenatide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, double blind, placebo controlled, weight loss, appetite, energy expenditure
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Exenatide First
Placebo First
Arm Description
Started on Exenatide, 3 week washout, start placebo
Started on placebo, 3 week washout, start exenatide
Outcomes
Primary Outcome Measures
Change in Weight
Change in weight at the end of each treatment period.
Change in Body Mass Index
Secondary Outcome Measures
Change in Waist Circumference
Systolic Blood Pressure
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
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
Diastolic Blood Pressure
Adiponectin
Change in Insulin
Change in Fasting Glucose
Change in Two Hour Glucose
HOMA Score
REE
Resting Energy Expenditure
Full Information
NCT ID
NCT00456885
First Posted
April 4, 2007
Last Updated
August 9, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Amylin Pharmaceuticals, LLC., Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00456885
Brief Title
The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
Official Title
The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Amylin Pharmaceuticals, LLC., Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Impaired Glucose Tolerance
Keywords
obesity, double blind, placebo controlled, weight loss, appetite, energy expenditure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exenatide First
Arm Type
Placebo Comparator
Arm Description
Started on Exenatide, 3 week washout, start placebo
Arm Title
Placebo First
Arm Type
Experimental
Arm Description
Started on placebo, 3 week washout, start exenatide
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta
Intervention Description
5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Twice daily injection of placebo
Primary Outcome Measure Information:
Title
Change in Weight
Description
Change in weight at the end of each treatment period.
Time Frame
16 weeks after the beginning of each treatment
Title
Change in Body Mass Index
Time Frame
16 weeks from the start of each treatment period.
Secondary Outcome Measure Information:
Title
Change in Waist Circumference
Time Frame
16 weeks from the start of each treatment period.
Title
Systolic Blood Pressure
Description
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.
Time Frame
16 weeks after the beginning of each treatment
Title
Changes in Body Composition
Description
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.
Time Frame
16 weeks after the beginning of each treatment
Title
Changes in Leptin
Time Frame
16 weeks from the start of each treatment period.
Title
Diastolic Blood Pressure
Time Frame
16 weeks after the beginning of each treatment
Title
Adiponectin
Time Frame
16 weeks after the beginning of each treatment
Title
Change in Insulin
Time Frame
16 weeks from the start of each treatment period.
Title
Change in Fasting Glucose
Time Frame
16 weeks from the start of each treatment period.
Title
Change in Two Hour Glucose
Time Frame
16 weeks from the start of each treatment period.
Title
HOMA Score
Time Frame
16 weeks from the start of each treatment period.
Title
REE
Description
Resting Energy Expenditure
Time Frame
16 weeks from the start of each treatment period.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleftheria Maratos-Flier, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22040840
Citation
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.
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The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
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