Phase 4
N=28
Bioenergetic Alterations After Exenatide Administration
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00623545 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Change in Energy Intake Measured Before Treatment and at the End of Treatment. — -167 kcal/d — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exenatide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Energy Intake Measured Before Treatment and at the End of Treatment. |
-167 | 0.001 sig |
| SECONDARY Weight Loss After Administration of Exenatide. |
-2.0 | < 0.05 sig |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00623545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.