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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Bioenergetic Alterations After Exenatide Administration

NCTNCT00623545 (opens ClinicalTrials.gov in a new tab)Other idH-2007-0235
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
28 participants (actual)
Sponsor
University of Wisconsin, Madison · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jan 2008
Primary completion
Apr 2010
Completion
Apr 2010
First posted
26 Feb 2008 (estimated)
Last update posted
9 Jan 2015 (estimated)
Conditions
Healthy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011
  1. Ph 4

    Bioenergetic Alterations After Exenatide Administration

    NCT00623545

    Jan 2008 to Apr 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • ExenatideDrug

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Energy Intake Measured Before Treatment and at the End of Treatment.

    Time frame · 3 months

    Registry description

    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)

  1. Weight Loss After Administration of Exenatide.

    Time frame · 3 months

    Registry description

    Body weight after overnight fast in light clothing

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3 months

Change in Energy Intake Measured Before Treatment and at the End of Treatment.

GroupValue (kcal/d)Spread
Exenitide Treatment-167173
Secondary and other outcome results(1)
Secondary outcomeMean· 3 months

Weight Loss After Administration of Exenatide.

GroupValue (kg)Spread
Exenitide Treatment-2.02.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Single Arm Study of Exenatide Treatment–0 / 286 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2012

8 results

Alterations in energy balance following exenatide administration.

Bradley et al. 2012Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolismecited by 39

PMID 22735035PMC3623676DOI 10.1139/h2012-068PUB-22735035

Rights unknown8 results
Source linkSee results (8)

More studies

1 study on this page

Indexing hint: Review · 2010

Exenatide and weight loss.

Bradley et al. 2010Nutrition (Burbank, Los Angeles County, Calif.)cited by 42

PMID 20152707DOI 10.1016/j.nut.2009.07.008PUB-20152707

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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