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Completed

NCT Number: NCT00623545

Bioenergetic Alterations After Exenatide Administration

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Univ Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.

Other names: Byetta

Primary outcomes

  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 outcomes

  1. Weight Loss After Administration of Exenatide.

    Time frame: 3 months

    Body weight after overnight fast in light clothing

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 26, 2008
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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