Effects of Leptin Replacement in Children
Phase 2
Completed
- Conditions
- ObesityDiabetesMetabolic Syndrome
- Interventions
- Drug: Recombinant methionyl human leptin
- Registration Number
- NCT00659828
- Lead Sponsor
- University of Miami
- Brief Summary
To assess the endocrine and immune effects of leptin replacement in leptin-deficient children, from a consanguineous family. The hypothesis is that leptin replacement will have significant effects on endocrine function.
- Detailed Description
The proposed study of the treatment of a child with congenital leptin deficiency will permit to elucidate key aspects of human endocrine function, and will give new insights on the role of leptin in human endocrine regulation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1
Inclusion Criteria
- Children with a functional leptin gene mutation from a consanguineous Turkish family. Only one leptin-naïve child from this family is alive and eligible.
Exclusion Criteria
- N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Recombinant Methionyl Human Leptin Recombinant methionyl human leptin Recombinant methionyl human leptin: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss).
- Primary Outcome Measures
Name Time Method Weight Baseline, 58 months
- Secondary Outcome Measures
Name Time Method Glucose Levels Baseline, 58 months Bone Mineral Density Baseline, 58 months
Trial Locations
- Locations (1)
University of Miami, Center on Pharmacogenomics
🇺🇸Miami, Florida, United States