The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects
- Obesity can lead to a number of health problems, including diabetes, heart disease, stroke, low back pain, fatty liver disease, and osteoarthritis. The medical treatments currently available for obesity are limited.
- Exenatide is an injectable medication approved for treatment of Type 2 diabetes that causes weight loss in some diabetic subjects. If exenatide works for weight loss in nondiabetic persons is not known.
- To determine whether nondiabetic obese individuals treated with exenatide as compared with those treated with placebo will lose a greater amount of weight and have body composition changes over a 24-week period, and whether the loss and body composition changes will be maintained during a 24-week extension period.
- To determine whether exenatide leads to a decrease in food intake.
- To determine whether change in caloric intake correlates with exenatide-induced changes in stomach emptying time.
- To determine the effects of exenatide on energy expenditure.
- To determine the effects of exenatide on carbohydrate versus fat use by the body for energy needs.
- To determine the effects of exenatide on activity levels.
- To determine whether exenatide alters hormonal levels, and the association of any changes with energy intake and expenditure, future weight loss, and percent body fat changes.
- To determine whether exenatide alters responses to behavioral testing via questionnaires specifically addressing dietary restraint and stress-related eating behaviors and the relationship of any changes to food intake, hormone levels, weight loss, and fat loss.
- To assess the tolerability and safety profile of exenatide in nondiabetic obese subjects.
- Nondiabetic men and (premenopausal) women between the ages of 18 and 55 years who have a body mass index greater than 30 kg/m(2) and live in the Phoenix, AZ area.
- Participants will be admitted for an initial 16-day period to the research unit, during which the following will occur:
- Instructions on lifestyle changes to promote weight loss
- Questionnaires to determine eating-related behaviors and attitudes toward food
- Laboratory testing to determine glucose tolerance, body composition, stomach emptying time, hormone levels, energy expenditure and food intake both before and after starting the study medication
- Instructions on self-injecting exenatide or placebo via a medication pen
- Instructions on the use of blood glucose monitors and logs
- Following release, participants will self-administer a set dose of either exenatide or a placebo 2 times per day for 24 weeks. Participants will not know whether they are receiving exenatide or placebo.
- Outpatient visits occur weekly for the first 4 weeks and then once every 4 weeks, during which weight loss, compliance with self-medication, side effects, and lifestyle modifications will be assessed.
- Participants will be readmitted to the metabolic unit during the 24th week of the study, during which the studies from the initial stay will be repeated.
- Participants wishing to continue into the 24-week open-label extension period will be seen as outpatients as described in the initial part of the study.
Drug: Byetta (exenatide)
Behavioral: Weight loss
Other: Metabolic Chamber
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effects of Exenatide (Byetta) on Energy Expenditure and Weight Loss in Non-Diabetic Obese Subjects|
- Exenatide effects on weight loss, energy expenditure & amp; food intake and to assess the safety profile of exenatide in non-diabetic obese people. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Weight loss maintenance, decreased fat mass, decreased food intake and increased energy expenditure with extended exenatide treatment [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Exenatide
10 micrograms subcutaneously twice
Drug: Byetta (exenatide)
Exenatide is an injectable medicationBehavioral: Weight loss
Because response to weight loss
Placebo Comparator: Placebo
Other: Metabolic Chamber
The subject stays in the small roomDrug: Placebo
Obesity can lead to a number of health problems including diabetes, heart disease, stroke, low back pain, fatty liver disease, and osteoarthritis. The medical treatments currently available for obesity are limited. Exenatide is an injectable medication approved for treatment of type 2 diabetes that causes weight loss in some diabetic subjects. The reasons exenatide is thought to cause weight loss include decreased food intake, increased feelings of fullness and nausea. Because levels of a human gut hormone (glucagon like peptide 1) that is similar to exenatide have been shown to be related to resting energy expenditure, it is also possible that exenatide may have effects on a person s metabolism, a.k.a. energy expenditure, but any effect of exenatide on energy expenditure has yet to be evaluated. Even though exenatide is used to treat diabetes, administration of exenatide to non-diabetic lean individuals did not cause frankly low blood sugars.
The primary goal of this study is to investigate the use of exenatide given twice a day as a weight loss medication in obese (BMI greater than or equal to 30 kg/m(2)) people without diabetes. Because response to weight loss treatment can be highly variable between individuals, our other goals will be to look at the role of exenatide related changes in food intake and energy expenditure as possible explanations for weight loss. We will also assess the safety profile of exenatide in non-diabetic obese people.
This study will involve the use of exenatide or placebo, determined randomly, in obese individuals without diabetes over a 5-week period. The primary measurements will include effects of exenatide on energy expenditure and food intake. We will also look at changes in body fat and the levels of hormones involved in the sensations of hunger and fullness. We will assess if any exenatide-induced changes can predict which individuals lose weight over the 5 weeks. The safety and side effects of exenatide in non-diabetic individuals during this time will also be determined. Findings from this study would help to determine how exenatide works to cause weight loss in people without diabetes, who might benefit most, and would help to improve understanding of why some people respond better to weight loss treatment than others.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856609
|Contact: Marie S. Thearle, M.D.||(602) firstname.lastname@example.org|
|United States, Arizona|
|Phoenix, Arizona, United States, 85014|
|Contact: Marie Thearle, M.D. 602-200-5304 email@example.com|
|Principal Investigator:||Marie S. Thearle, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|