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:||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 Intake Measured Before Treatment and at the End of Treatment. [ Time Frame: 3 months ] [ Designated as safety issue: No ]Energy intake is as calculated from energy expenditure as measured by doubly labeled water and change in body energy stores before and at the end of treatment. Units are kcal/d.
- Weight Loss After Administration of Exenatide. [ Time Frame: 3 months ] [ Designated as safety issue: No ]Body weight after overnight fast in light clothing
|Study Start Date:||January 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Exenatide. Dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks Each subject serves as their own control for outcome measures taken before and during drug treatment.
Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.
Other Name: Byetta
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 Univ. Wisconsin 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|
|Univ Wisconsin Hospital and Clinics|
|Madison., Wisconsin, United States, 53792|
|Principal Investigator:||David P Bradley, MD||University of Wisconsin, Madison|