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| Name | Class |
|---|---|
| Office of Dietary Supplements (ODS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chromium Picolinate | Active Comparator | HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months. |
|
| Placebo | No Intervention | HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chromium picolinate | Dietary Supplement | HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in insulin sensitivity | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie C. Gelato, MD, PhD | State University of New York/General Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York/General Clinical Research Center | Stony Brook | New York | 11794 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15807717 | Background | 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. doi: 10.1111/j.1468-1293.2005.00273.x. | |
| 15844072 | Background | 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. doi: 10.1086/429824. Epub 2005 Apr 11. |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C030614 | picolinic acid |
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| 15844237 | Background | Taiwo BO. Insulin resistance, HIV infection, and anti-HIV therapies. AIDS Read. 2005 Apr;15(4):171-6, 179-80. |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |