Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362440
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2006-08-09
Brief Title:
Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
A Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome A Randomized Double-blind Placebo-controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-02
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:
The purpose of this study is to determine whether patients with HIV lipodystrophy fat wasting benefit from taking the combination of two drugs one insulin sensitizer either metformin or pioglitazone both diabetes drugs and leptin a natural hormone produced by your fat cells Our hope is that they will improve sugar and fat metabolism and positively affect the body fat changes you have noticed while taking HAART
Detailed Description:
Highly active antiretroviral therapy HAART induces profound and sustained suppression of human immunodeficiency virus HIV replication and is thus very effective in reducing disease-associated morbidity and mortality in this patient population However HAART also results in the development of a lipodystrophic syndrome which is characterized by fat accumulation fat wasting or a combination of both and similar to congenital forms of lipodystrophy is associated with components of the metabolic syndrome including insulin resistance IR fasting hypertriglyceridemia and hypercholesterolemia
Our study is a proof of concept study on the treatment of the HAART-induced metabolic syndrome which builds upon and represents a direct extension of a study previously funded by the American Diabetes Association ADA If our clinical trial proves that a combination treatment of leptin and an insulin sensitizer has additive or synergistic effects in reversing the metabolic abnormalities of HIV positive patients with lipoatrophy it could lead to the design of larger multi-center randomized placebo-controlled trials aiming at establishing safety and efficacy of this treatment for the HAART-induced metabolic syndrome
Our study is a proof of concept study on the treatment of the HAART-induced metabolic syndrome which builds upon and represents a direct extension of a study previously funded by the American Diabetes Association ADA If our clinical trial proves that a combination treatment of leptin and an insulin sensitizer has additive or synergistic effects in reversing the metabolic abnormalities of HIV positive patients with lipoatrophy it could lead to the design of larger multi-center randomized placebo-controlled trials aiming at establishing safety and efficacy of this treatment for the HAART-induced metabolic syndrome
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