Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-04-09 @ 1:12 PM
Study NCT ID:
NCT00657605
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2008-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Human Leptin Replacement
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
Effects of Human Leptin Replacement
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 rhythms during the course of leptin-replacement treatment in the only three adult individuals identified in the world so far who are leptin-naive due to a functional leptin gene mutation. A study of leptin-naive subjects avoids all confounding factors and pitfalls, because the only bioactive leptin to which they will be exposed is the exogenously administered recombinant protein. Thus, this proposal will permit us to ascertain the endocrine effects of human leptin.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R0IDK58851-01 | OTHER | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | View |