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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. Identifier: NCT00623545
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : January 9, 2015
Last Update Posted : January 9, 2015
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Drug: Exenatide Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioenergetic Alterations After Exenatide Administration
Study Start Date : January 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: Exenatide
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
Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.
Other Name: Byetta

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Weight Loss After Administration of Exenatide. [ Time Frame: 3 months ]
    Body weight after overnight fast in light clothing

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00623545

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United States, Wisconsin
Univ Wisconsin Hospital and Clinics
Madison., Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
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Principal Investigator: David P Bradley, MD University of Wisconsin, Madison
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison Identifier: NCT00623545    
Other Study ID Numbers: H-2007-0235
First Posted: February 26, 2008    Key Record Dates
Results First Posted: January 9, 2015
Last Update Posted: January 9, 2015
Last Verified: January 2015
Keywords provided by University of Wisconsin, Madison:
weight loss
energy expenditure
normal volunteers
Additional relevant MeSH terms:
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Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Hormones, Hormone Substitutes, and Hormone Antagonists