Obesity
Conditions
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.
Interventions
DRUGSandostatin LAR
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients ages 6 to less than 18 * Patients who have experienced any form of cranial insult related to cranial trauma, or to a tumor or it's treatment (i.e. surgery, radiation, and/or chemotherapy) * Patients who are at least one year out following therapy for their tumor * Patients who have severe cardiovascular dysfunction (for example cardiomyopathy, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation) will be excluded * Patients with severe neurologic handicaps which preclude normal physical activity will be excluded. * Patients confined to bed and those patients who are wheelchair bound which prevents them from activities of daily living or normal physical activity, i.e. walking, will be excluded from the trial * Your child must be greater than 120% of their ideal body weight for their height or have a body mass index that is greater than or equal to 27.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in BMI | — |
Secondary
| Measure | 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 | — |
Countries
United States
Outcome results
None listed