Pediatric Hypothalamic Obesity
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
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)
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Colorado
🇺🇸Denver, Colorado, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
St. Vincent Children's Center for Cancer and Blood Diseases
🇺🇸Indianapolis, Indiana, United States
Childrens Memorial Hospital
🇺🇸Chicago, Illinois, United States
UT Southwestern Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
Miami Children'S Hopital
🇺🇸Miami, Florida, United States
Phoenix Children'S Hospital
🇺🇸Phoenix, Arizona, United States
U of Tennessee HELP Center
🇺🇸Memphis, Tennessee, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States