Pediatric Hypothalamic Obesity

Phase 4

Completed

• Conditions: Obesity

• Registration Number: NCT00076362
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ that secretes hormones). The purpose of this trial is to see how an investigational treatment controls the hormone insulin by lowering the level of insulin in the body resulting in a weight loss in children who are at least 6 years of age but less than 18 years of age. Some children in this trial will receive placebo.

To qualify for this study, you and your child's doctor must feel that your child's weight is inadequately controlled within a year from the time of injury to the hypothalamus or tumor of the hypothalamus. This study will help to determine if an investigational treatment is of benefit in controlling a child's weight.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-01-21
• Study First Submitted QC: 2004-01-22
• Study First Posted: 2004-01-23
• Study Start: 2004-03
• Primary Completion: 2005-07
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-08
• Last Update Posted: 2011-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in BMI

Secondary Outcome Measures

Name	Time	Method
Change from baseline in weight, leptin, insulin AUC, C-peptide AUC, amylin AUC, glucose AUC, dietary intake, physical activity, waist-to-hip ratio, visceral and subcutaneous abdominal fat

Trial Locations

Locations (15)

Phoenix Children'S Hospital; 🇺🇸 Phoenix, Arizona, United States

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

Miami Children'S Hopital; 🇺🇸 Miami, Florida, United States

Childrens Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

St. Vincent Children's Center for Cancer and Blood Diseases; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

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