Status:
COMPLETED
Effects of Human Leptin Replacement
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Metabolic Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.
Detailed Description
The study aims to elucidate the role of leptin in the regulation of human endocrine function approached by a carefully designed, prospective clinical study of the rapidly-sampled dynamics of endocrine...
Eligibility Criteria
Inclusion
- Congenital leptin deficiency (these are only 3 adult individuals in the world that have been identified as leptin-naïve thus far).
Exclusion
- Pregnant, trying to become pregnant, breast-feeding an infant or sexually active women, not using contraception.
- Subjects with hemoglobin levels below 12 g/dl.
- Subjects whose body contains a ferromagnetic implanted device that might produce a safety hazard during fMRI.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00657605
Start Date
June 1 2001
End Date
May 4 2010
Last Update
February 13 2020
Active Locations (1)
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1
University of Miami Miller School of Medicine, Center on Pharmacogenomics
Miami, Florida, United States, 33136