Expired Study
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Stony Brook, New York 11794


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - HIV infected - Currently taking an anti-HIV drug regimen - Insulin Resistant:fasting glucose between 5.56 and 7mmol/L and/or two hour post-glucose load between 7.78 and 11.11mmol/L Exclusion Criteria: - Cancer - Acute illness that would interfere with the study - Hypogonadism - Hypothyroidism - Untreated hypertension - CD4 count less than 300 cells/mm3 - Viral load greater than 35,000 copies/ml - Untreated hepatitis C virus infection - Pregnancy - Diabetes


Study is Available At:


Original ID:

R21 AT002499-01A1


NCT ID:

NCT00109746


Secondary ID:


Study Acronym:

NT


Brief Title:

Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults


Official Title:

A Novel Therapy for Glucose Intolerance in HIV Disease


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Complementary and Integrative Health (NCCIH)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

39


Enrollment Type:

Actual


Overall Contact Information

Official Name:Marie C. Gelato, MD, PhD
Principal Investigator
State University of New York/General Clinical Research Center

Study Dates

Start Date:November 2005
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:May 2009
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:March 22, 2016
First Received Date:May 2, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Improvement in insulin sensitivity
Time Frame:8 weeks
Safety Issues:True

Study Interventions

Intervention Type:Dietary Supplement
Name:chromium picolinate
Description:HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
Arm Name:Chromium Picolinate

Study Arms

Study Arm Type:Active Comparator
Arm Name:Chromium Picolinate
Description:HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
Study Arm Type:No Intervention
Arm Name:Placebo
Description:HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Complementary and Integrative Health (NCCIH)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Office of Dietary Supplements (ODS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:El-Sadr WM, Mullin CM, Carr A, Gibert C, Rappoport C, Visnegarwala F, Grunfeld C, Raghavan SS. Effects of HIV disease on lipid, glucose and insulin levels: results from a large antiretroviral-naive cohort. HIV Med. 2005 Mar;6(2):114-21.
PMID:15807717
Reference Type:Reference
Citation:Howard AA, Floris-Moore M, Arnsten JH, Santoro N, Fleischer N, Lo Y, Schoenbaum EE. Disorders of glucose metabolism among HIV-infected women. Clin Infect Dis. 2005 May 15;40(10):1492-9. Epub 2005 Apr 11.
PMID:15844072
Reference Type:Reference
Citation:Taiwo BO. Insulin resistance, HIV infection, and anti-HIV therapies. AIDS Read. 2005 Apr;15(4):171-6, 179-80. Review.
PMID:15844237

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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