Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults (NT)
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ClinicalTrials.gov Identifier: NCT00109746 |
Recruitment Status :
Completed
First Posted : May 3, 2005
Last Update Posted : March 23, 2016
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Condition or disease | Intervention/treatment | Phase |
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Insulin Resistance HIV Infections | Dietary Supplement: chromium picolinate | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Health Services Research |
Official Title: | A Novel Therapy for Glucose Intolerance in HIV Disease |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
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Active Comparator: Chromium Picolinate
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
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Dietary Supplement: chromium picolinate
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months. |
No Intervention: Placebo
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
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- Improvement in insulin sensitivity [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109746
United States, New York | |
State University of New York/General Clinical Research Center | |
Stony Brook, New York, United States, 11794 |
Principal Investigator: | Marie C. Gelato, MD, PhD | State University of New York/General Clinical Research Center |
Responsible Party: | Marie Gelato, Principal Investigator, Stony Brook University |
ClinicalTrials.gov Identifier: | NCT00109746 |
Other Study ID Numbers: |
R21 AT002499-01A1 |
First Posted: | May 3, 2005 Key Record Dates |
Last Update Posted: | March 23, 2016 |
Last Verified: | May 2013 |
HIV Treatment Experienced Anti-Retroviral Agents |
Antiretroviral Therapy, Highly Active Picolinic acid Dietary Supplements |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Chromium Picolinic acid Trace Elements Micronutrients |
Nutrients Growth Substances Physiological Effects of Drugs Iron Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |