Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140244
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2005-08-30
Brief Title:
Randomized Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Role of Leptin in Highly Active Antiretroviral Therapy HAART-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients
Status:
COMPLETED
Status Verified Date:
2017-04
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:
The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution lipid profile and other metabolic problems associated with highly active antiretroviral therapy HAART-induced lipodystrophy and metabolic syndrome in HIV patients
Detailed Description:
Exposure to HIV medications has been associated with metabolic changes including generalized fat depletion lipoatrophy high triglyceride levels and in some patients high sugar levels or diabetes This syndrome is associated with a deficiency of leptin a hormone produced by fat cells Recent studies involving leptin administration to patients with congenital lipoatrophy have shown dramatic improvements in metabolic parameters such as insulin resistance and hyperlipidemia Leptin administration to patients with HAART-induced lipoatrophy may also lead to significant improvements in the metabolic abnormalities found in these HIV patients The aims of this study are to examine the effect of leptin administration on insulin resistance and other parameters of the metabolic syndrome in HIV patients with HAART-induced lipoatrophy
Comparison Leptin-treated group to placebo-treated group
Comparison Leptin-treated group to placebo-treated group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK058785 | NIH | None | httpsreporternihgovquickSearchR01DK058785 |