Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246402
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2005-10-27
Brief Title:
Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Anti-Lipolytic Strategy for HIV Lipodystrophy
Status:
COMPLETED
Status Verified Date:
2007-12
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 test whether chronic administration of the drug acipimox will improve hyperlipidemia and insulin sensitivity among HIV infected patients experiencing highly active antiretroviral therapy HAART associated metabolic disturbances
Detailed Description:
BACKGROUND
HIV infected patients treated with HAART are at increased risk for developing significant dyslipidemia insulin resistance and abnormal patterns of fat distribution While the exact mechanism responsible for these changes is not known there is increasing evidence that patients with HIV infection and fat redistribution have increased basal rates of lipolysis and elevated circulating free fatty acids FFA Patients with HIV associated lipodystrophy have increased FFA levels that correlated directly with impaired glucose metabolism and triglyceride concentrations Furthermore acute inhibition of lipolysis in patients with HIV lipodystrophy and insulin resistance results in improvement in insulin sensitivity However long-term administration of lipolytic blocking agents has not been evaluated in this patient population Acipimox a nicotinic acid analogue and a potent inhibitor of lipolysis is an established therapy for dyslipidemia In addition through effects on lowering circulating FFA acute administration of acipimox has been shown to improve insulin sensitivity in other populations including lean and obese individuals and patients with type II diabetes This study will test the hypothesis that chronic administration of acipimox will improve hyperlipidemia and insulin sensitivity among HIV infected patients experiencing HAART associated metabolic disturbances
DESIGN NARRATIVE
The study will be a 3-month double-blind placebo-controlled trial of 250 mg of acipimox three times daily in 30 patients with HAART lipodystrophy The primary clinical endpoint of this study will be the change in fasting triglyceride concentration comparing baseline values to those obtained after 3 months of acipimox or placebo Insulin sensitivity an important secondary endpoint will be determined by hyperinsulinemic euglycemic clamp studies Rates of lipolysis in the fasting state will be quantified by a 3-hour infusion of stable isotope-labeled glycerol Indirect calorimetry will be used to assess changes in resting energy expenditure Cross-sectional computed tomography CT imaging of the thigh and abdomen will allow for measurement of visceral and subcutaneous fat areas Dual energy x-ray absorptiometry DEXA will be used to determine whole body fat mass
HIV infected patients treated with HAART are at increased risk for developing significant dyslipidemia insulin resistance and abnormal patterns of fat distribution While the exact mechanism responsible for these changes is not known there is increasing evidence that patients with HIV infection and fat redistribution have increased basal rates of lipolysis and elevated circulating free fatty acids FFA Patients with HIV associated lipodystrophy have increased FFA levels that correlated directly with impaired glucose metabolism and triglyceride concentrations Furthermore acute inhibition of lipolysis in patients with HIV lipodystrophy and insulin resistance results in improvement in insulin sensitivity However long-term administration of lipolytic blocking agents has not been evaluated in this patient population Acipimox a nicotinic acid analogue and a potent inhibitor of lipolysis is an established therapy for dyslipidemia In addition through effects on lowering circulating FFA acute administration of acipimox has been shown to improve insulin sensitivity in other populations including lean and obese individuals and patients with type II diabetes This study will test the hypothesis that chronic administration of acipimox will improve hyperlipidemia and insulin sensitivity among HIV infected patients experiencing HAART associated metabolic disturbances
DESIGN NARRATIVE
The study will be a 3-month double-blind placebo-controlled trial of 250 mg of acipimox three times daily in 30 patients with HAART lipodystrophy The primary clinical endpoint of this study will be the change in fasting triglyceride concentration comparing baseline values to those obtained after 3 months of acipimox or placebo Insulin sensitivity an important secondary endpoint will be determined by hyperinsulinemic euglycemic clamp studies Rates of lipolysis in the fasting state will be quantified by a 3-hour infusion of stable isotope-labeled glycerol Indirect calorimetry will be used to assess changes in resting energy expenditure Cross-sectional computed tomography CT imaging of the thigh and abdomen will allow for measurement of visceral and subcutaneous fat areas Dual energy x-ray absorptiometry DEXA will be used to determine whole body fat mass
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 |
|---|---|---|---|
| R21HL073675 | NIH | None | httpsreporternihgovquickSearchR21HL073675 |