Bioenergetic Alterations After Exenatide Administration

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Bioenergetic Alterations After Exenatide Administration

Conditions
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Healthy

Intervention / Treatment
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* Drug: Exenatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years of age BMI between 30 and 40 kg/m2 Women with a negative pregnancy test at baseline, who are sterile, using contraceptives or in a committed relationship with someone who is sterile or using contraception Absence of weight change greater than 3 kg in the previous 6 months Exclusion Criteria: Women who are pregnant or lactating Current or recent (6 months) enrollment in a commercial or self prescribed weight loss or exercise program Use of weight loss medication A history of metabolic disease i.e. renal, endocrine, hepatic or gastrointestinal disease that would impact the outcome of the study Presence of medical conditions that are known to affect energy expenditure (i.e. hyperthyroidism, rheumatoid arthritis, AIDS among others) History of hypoglycemia A history of psychiatric or eating disorder Abnormal EKG Previous history of pancreatitis Previous history of gastroparesis or GI motility disorder Use of medications that can affect GI motility History of organ transplantation Other comorbid conditions which may preclude the subject's ability to complete the study Use of a carbonic anhydrase inhibitor such as acetazolamide

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide<br>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. | Drug: Exenatide<br>* Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.<br>* Other names: Byetta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Energy Intake Measured Before Treatment and at the End of Treatment. | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss After Administration of Exenatide. | Body weight after overnight fast in light clothing | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exenatide, Byetta, weight loss, energy expenditure, normal volunteers