Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109746
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2005-05-02
Brief Title:
Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
A Novel Therapy for Glucose Intolerance in HIV Disease
Status:
COMPLETED
Status Verified Date:
2013-05
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:
NT
Brief Summary:
The purpose of this study is to determine the effectiveness of the nutritional supplement chromium picolinate in improving insulin resistance a symptom of diabetes in HIV-infected patients The ultimate goal is to find a simple therapy that can prevent the development of diabetes in individuals with HIV
Detailed Description:
Insulin resistance occurs when blood glucose levels get too high for the body to respond Certain anti-HIV drugs are associated with increased insulin resistance and may lead to abnormal fat distribution hypertension and type 2 diabetes mellitus The dietary supplement chromium picolinate has been shown to safely improve insulin sensitivity in patients with type 2 diabetes mellitus with no serious side effects However the effects of the supplement have not been thoroughly examined in HIV-infected individuals This study will determine the effectiveness of chromium picolinate in improving insulin resistance in HIV-infected individuals
This study will last 2 months Participants will be randomly assigned to receive either chromium picolinate or placebo once a day for 2 months Participants will have four overnight visits at the research center and two additional daytime visits for safety monitoring During the overnight visits participants will undergo a euglycemic hyperinsulinemic clamp in which a continuous infusion of insulin is given through a vein and glucose levels are monitored through blood samples taken every 5 to 10 minutes Fat tissue biopsies will also be conducted at the overnight study visits During the safety monitoring visits blood collection will occur for kidney and liver function tests CD4 count and viral load assessment
This study will last 2 months Participants will be randomly assigned to receive either chromium picolinate or placebo once a day for 2 months Participants will have four overnight visits at the research center and two additional daytime visits for safety monitoring During the overnight visits participants will undergo a euglycemic hyperinsulinemic clamp in which a continuous infusion of insulin is given through a vein and glucose levels are monitored through blood samples taken every 5 to 10 minutes Fat tissue biopsies will also be conducted at the overnight study visits During the safety monitoring visits blood collection will occur for kidney and liver function tests CD4 count and viral load assessment
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