Bioenergetic Alterations After Exenatide Administration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00623545
First received: February 14, 2008
Last updated: January 5, 2015
Last verified: January 2015
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioenergetic Alterations After Exenatide Administration

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Energy Intake Measured Before Treatment and at the End of Treatment. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Weight Loss After Administration of Exenatide. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Body weight after overnight fast in light clothing


Enrollment: 28
Study Start Date: January 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
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, see Learn About Clinical Studies.

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

Locations
United States, Wisconsin
Univ Wisconsin Hospital and Clinics
Madison., Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: David P Bradley, MD University of Wisconsin, Madison
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00623545     History of Changes
Other Study ID Numbers: H-2007-0235
Study First Received: February 14, 2008
Results First Received: July 22, 2013
Last Updated: January 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Exenatide
Byetta
weight loss
energy expenditure
normal volunteers

Additional relevant MeSH terms:
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 04, 2015