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Trial · Interventional

CompletedPhase 2Results postedRegistry data

GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children

NCTNCT00886626 (opens ClinicalTrials.gov in a new tab)Other id0902M59181
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
12 participants (actual)
Sponsor
University of Minnesota · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
May 2009
Primary completion
Feb 2011
Completion
Feb 2011
First posted
23 Apr 2009 (estimated)
Last update posted
29 Oct 2012 (estimated)
Conditions
Obesity, Morbid

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 2

    GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children

    NCT00886626

    May 2009 to Feb 2011

Registry summary

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

The prevalence of severely obese children is on the rise. Behavioral therapies for weight loss are successful in some, but others need more aggressive approaches such as drug therapy. In addition, up to 25% of severely obese children have impaired glucose tolerance (IGT), which places them at significantly elevated risk of developing type 2 diabetes mellitus and cardiovascular disease. Although various drug therapies for weight loss and IGT have been explored in adults, few have been evaluated in children. Recently, a new drug class has emerged that targets deficiencies of GLP-1. One of the main glycemic mechanisms of action of the GLP-1 agonists such as exenatide is to enhance glucose disposal in the postprandial setting and improve glucose tolerance. In addition, exenatide can induce weight loss by decreasing appetite and slowing gastric motility.

Interventions

  • ExenatideDrug

Arms2

  • Experimental

    Exenatide

    Exenatide

  • No intervention

    Control

    Control - no intervention

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Body Mass Index (BMI)

    Time frame · 3-month

    Registry description

    Change in body mass index (BMI) over three months

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-month

Change in Body Mass Index (BMI)

GroupValue (change in kg/m^2)Spread
Exenatide-0.91.2
Control0.841.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ExenatideExenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months.–0 / 114 / 11
ControlNo medication control for 3-months.–0 / 110 / 11

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

7 results

Exenatide as a weight-loss therapy in extreme pediatric obesity: a randomized, controlled pilot study.

Kelly et al. 2012Obesity (Silver Spring, Md.)cited by 113

PMID 22076596PMC3684414DOI 10.1038/oby.2011.337PUB-22076596

Rights unknown7 results
Source linkSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 8 Years up to 19 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age 8-19 years old * Subject able to give assent, and parent/guardian capable of giving consent on behalf of the child * Body mass index (BMI) ≥ 99th percentile (based on gender and age) Exclusion Criteria: * Type 1 or 2 diabetes mellitus * Initiation of a new drug therapy within the past 30 days prior to the screening visit * BMI ≥ 55 * History of weight loss surgery * Obesity from a genetic cause (e.g., Prader-Willi) * Central nervous system injury or severe neurological impairment * Known systolic or diastolic dysfunction or heart failure * Females who are currently pregnant or planning to become pregnant * Liver enzymes \> 2.5 times upper limit of normal * Severe renal impairment (defined as creatinine clearance \<30 mL/min) * Gastrointestinal disease

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