NCT00623545

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Jan 2008

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

January 9, 2015

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.2 years

First QC Date

February 14, 2008

Results QC Date

July 22, 2013

Last Update Submit

January 5, 2015

Conditions

Healthy

Keywords

ExenatideByettaweight lossenergy expenditurenormal volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Weight Loss After Administration of Exenatide.

    3 months

Study Arms (1)

Exenatide

EXPERIMENTAL

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

Interventions

ExenatideDRUG

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

Also known as: Byetta
Exenatide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

  • 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.

    PMID: 20152707RESULT

  • 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.

    PMID: 22735035DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Limitations and Caveats

study was limited by the number of subjects who did not complete the study as a result of nausea. The nausea was short-lived and mild in all subjects that completed the study.

Results Point of Contact

Title
Dale A Schoeller
Organization
University of Wisconsin-Madison
dschoell@nutrisci.wisc.edu
608-262-1082

Study Officials

  • David P Bradley, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 26, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

January 9, 2015

Results First Posted

January 9, 2015

Record last verified: 2015-01

Locations

US(1)