Bioenergetic Alterations After Exenatide Administration - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00623545

Purpose

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	Intervention	Phase
Healthy	Drug: Exenatide	Phase IV

MedlinePlus related topics: Weight Control

Drug Information available for: Exenatide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Bioenergetic Alterations After Exenatide Administration

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Weight loss after administration of exenatide. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	26
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Exenatide 10mcg subcutaneously BID x 28 additional days of treatment.

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623545

Contacts

Contact: Andrea L. Maser, MS	608-265-6544	alm@clinicaltrials.wisc.edu
Contact: Roger Kulstad, MD	608-263-7780	rkulstad@uwhealth.org

Locations

United States, Wisconsin
University of Wisconsin Hospital & Clinics	Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Roger Kulstad, MD

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Roger Kulstad, MD

University of Wisconsin, Madison

More Information

Responsible Party:	University of WIsconsin ( Roger Kulstad, MD )
Study ID Numbers:	H-2007-0235
Study First Received:	February 14, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00623545
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

Exenatide
Byetta
weight loss
energy expenditure
normal volunteers

Study placed in the following topic categories:

Body Weight
Exenatide
Weight Loss
Healthy

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009