Bioenergetic Alterations After Exenatide Administration
The purpose of this study is to find out how exenatide causes weight loss. Specifically, the study is assessing how exenatide may change how people take in energy (energy intake), as well as how it may effect how people use energy (energy expenditure).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bioenergetic Alterations After Exenatide Administration|
- Change in energy expenditure and energy intake as measured by doubly labeled water and change in body energy stores. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Weight loss after administration of exenatide. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
The bioenergetics study is looking at how and why the diabetes drug exenatide causes people to lose weight.Bioenergetics is the study of how your body burns calories.
Adults 18-65 who do not have diabetes and have a body mass index (BMI) between 30 and 40 may be eligible. Women who could get pregnant must be on birth control during the study and women who are pregnant cannot participate in the study.
Subjects will take exenatide for 12 weeks. There are 6 study visits in the UW Hospital General Clinical Research Center. Visits range from 1 to 6 hours and include blood and urine tests, resting metabolic rate testing over a four hour period, physical exam, ECG, and a be bone mineral density testing at another clinic during 2 clinic visits of the study.
All study procedures and testing are free of charge.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623545
|United States, Wisconsin|
|UW Hospital and Clinics|
|Madison., Wisconsin, United States, 53792|
|Principal Investigator:||David P Bradley, MD||University of Wisconsin, Madison|