Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Endocrine |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2005 |
| End Date: | June 2010 |
A Novel Therapy for Glucose Intolerance in HIV Disease
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.
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.
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.
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
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