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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sandostatin LAR | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in BMI |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children'S Hospital | Phoenix | Arizona | 85016 | United States | ||
| Children's Hospital of Orange County |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Orange |
| California |
| 92868 |
| United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado | Denver | Colorado | 80218 | United States |
| Miami Children'S Hopital | Miami | Florida | 33155 | United States |
| Childrens Memorial Hospital | Chicago | Illinois | 60614 | United States |
| St. Vincent Children's Center for Cancer and Blood Diseases | Indianapolis | Indiana | 46260 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| U of Tennessee HELP Center | Memphis | Tennessee | 38103 | United States |
| UT Southwestern Children's Medical Center of Dallas | Dallas | Texas | 75390 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |