Bioenergetic Alterations After Exenatide Administration
|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.|
|ClinicalTrials.gov Identifier: NCT00623545|
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : January 9, 2015
Last Update Posted : January 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Exenatide||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bioenergetic Alterations After Exenatide Administration|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
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
- Change in Energy Intake Measured Before Treatment and at the End of Treatment. [ Time Frame: 3 months ]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 ]Body weight after overnight fast in light clothing
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): NCT00623545
|United States, Wisconsin|
|Univ Wisconsin Hospital and Clinics|
|Madison., Wisconsin, United States, 53792|
|Principal Investigator:||David P Bradley, MD||University of Wisconsin, Madison|