Phase 2
N=1
Effects of Leptin Replacement in Children
Obesity · Metabolic Syndrome · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00659828 ↗Enrolled (actual)
1
Serious AEs
—
Results posted
Feb 2020
Primary outcome: Primary: Weight — NA lbs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Recombinant methionyl human leptin (Drug)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
NA | — |
| SECONDARY Glucose Levels |
NA | — |
| SECONDARY Bone Mineral Density |
NA | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00659828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.