Status:

COMPLETED

Bioenergetic Alterations After Exenatide Administration

Lead Sponsor:

University of Wisconsin, Madison

Conditions:

Healthy

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

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 ma...

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 dia...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2010

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT00623545

Start Date

January 1 2008

End Date

April 1 2010

Last Update

January 9 2015

Active Locations (1)

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1

Univ Wisconsin Hospital and Clinics

Madison, Wisconsin, United States, 53792