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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Exenatide

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison., Wisconsin, United States, 53792
      • Univ Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Energy Intake Measured Before Treatment and at the End of Treatment.	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss After Administration of Exenatide.	Body weight after overnight fast in light clothing	3 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: David P Bradley, MD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• Bradley DP, Kulstad R, Schoeller DA. Exenatide and weight loss. Nutrition. 2010 Mar;26(3):243-9. doi: 10.1016/j.nut.2009.07.008.
• Bradley DP, Kulstad R, Racine N, Shenker Y, Meredith M, Schoeller DA. Alterations in energy balance following exenatide administration. Appl Physiol Nutr Metab. 2012 Oct;37(5):893-9. doi: 10.1139/h2012-068. Epub 2012 Jun 26.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: February 14, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): February 26, 2008

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 5, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: weight loss; Byetta; energy expenditure; Exenatide; normal volunteers
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: H-2007-0235