A Phase 1/2 interventional study of chromium picolinate in Insulin Resistance and HIV Infections, sponsored by National Center for Complementary and Integrative Health (NCCIH). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-23.
Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Phase 1/2, Interventional, and Health services research
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.
1,959 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.
This study's enrollment of 39 is close to the median of 40 across 1,535 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 218 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
Dietary Supplement: chromium picolinate
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
Improvement in insulin sensitivity
Time frame: 8 weeks
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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National Center for Complementary and Integrative Health (NCCIH)