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Exenatide in Extreme Pediatric Obesity

This study has been completed.
Sponsor:
Collaborator:
Children's Hospitals and Clinics of Minnesota
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01237197
First received: November 1, 2010
Last updated: September 4, 2014
Last verified: September 2014
Results First Received: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Drug: Exenatide
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the University of Minnesota, Amplatz Children’s Hospital Pediatric Weight Management Clinic in Minneapolis or the McNeely Pediatric Diabetes Center and Endocrinology Clinic, Children’s Hospitals and Clinics of Minnesota in St Paul.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Exenatide

Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)

Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.

Placebo Injection

Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.

Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.


Participant Flow for 2 periods

Period 1:   Randomization Period
    Exenatide     Placebo Injection  
STARTED     13     13  
COMPLETED     12     10  
NOT COMPLETED     1     3  

Period 2:   Open Label Period
    Exenatide     Placebo Injection  
STARTED     12     10  
COMPLETED     12     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Exenatide

Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)

Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.

Placebo Injection

Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.

Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.

Total Total of all reporting groups

Baseline Measures
    Exenatide     Placebo Injection     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: participants]
     
<=18 years     13     13     26  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  14.9  ± 1.76     15.5  ± 1.88     15.2  ± 1.8  
Gender  
[units: participants]
     
Female     8     8     16  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
United States     13     13     26  



  Outcome Measures

1.  Primary:   Percent Change From Baseline in Body Mass Index at 3-months   [ Time Frame: Baseline and 3-months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aaron S. Kelly, Ph.D.
Organization: University of Minnesota
phone: 612-626-3492
e-mail: kelly105@umn.edu


No publications provided by University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01237197     History of Changes
Other Study ID Numbers: 1009M88952
Study First Received: November 1, 2010
Results First Received: September 10, 2013
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board