Overview

Bioenergetic Alterations After Exenatide Administration

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
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 may effect how people use energy (energy expenditure).
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Wisconsin, Madison
Treatments:
Exenatide
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