Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025753
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-10-19
Brief Title:
Rosiglitazone and Exercise Training Effects on HIV-Infected People With Insulin Resistance Hypertriglyceridemia and Adipose Tissue Maldistribution
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Rosiglitazone and Exercise Training Effects on HIV-Infected People With Insulin Resistance Hypertriglyceridemia and Adipose Tissue Maldistribution
Status:
COMPLETED
Status Verified Date:
2003-12
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:
Several complications have become prevalent in people living with HIVAIDS including increased blood sugar increased blood fats and cholesterol and fat tissue redistribution The causes of these complications are not well understood and effective treatments have not been identified We propose to test the efficacy and safety of 2 treatments for these complications in people living with HIVAIDS aerobic weight lifting exercise training and a new insulin-sensitizing agent called rosiglitazone Avandia Exercise and rosiglitazone have been effective and moderately safe when used in HIV-seronegative people with diabetes but a specific trial is needed to test efficacy and safety in people living with HIVAIDS
Detailed Description:
We propose a 12wk controlled randomized trial that compares the effects of rosiglitazone therapy exercise training and combined rosiglitazone and exercise training We hypothesize that rosiglitazone will lower blood sugar insulin blood fats muscle and liver lipid content and composition in HIV-infected people Exercise training will induce the same benefits but will also reduce abdominal fat mass We hypothesize that combining exercise training with rosiglitazone therapy will be most effective at reducing blood sugar insulin lipids muscle and liver lipid contents and restoring body fat distribution than either intervention alone At baseline and after 12 wk of treatment we will measure the ability of insulin to promote the clearance of sugar from the blood the clearance rate of blood sugar the rate of glucose production by the liver blood fat and cholesterol concentrations body fat content and fat distribution in the arms legs trunk regions muscle and liver lipid content and composition
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: