Effects of Human Leptin Replacement

• Status: Completed
• Trial end date: 2010-05-04
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Criteria

Inclusion Criteria:

• Congenital leptin deficiency (these are only 3 adult individuals in the world that have been identified as leptin-naïve thus far).

Exclusion Criteria:

• 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.