Clinical trial NCT00109746: Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults
Official title: A Novel Therapy for Glucose Intolerance in HIV Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Insulin Resistance
HIV Infections
Keywords: HIV
Treatment Experienced
Anti-Retroviral Agents
Antiretroviral Therapy, Highly Active
Picolinic acid
Dietary Supplements
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: Office of Dietary Supplements (ODS)
First posted: 2005-05-03
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Improvement in insulin sensitivity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: State University of New York/General Clinical Research Center
state: New York
Study officials:
affiliation: State University of New York/General Clinical Research Center
name: Marie C. Gelato, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1468-1293.2005.00273.x.
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. doi: 10.1086/429824. Epub 2005 Apr 11.
citation: Taiwo BO. Insulin resistance, HIV infection, and anti-HIV therapies. AIDS Read. 2005 Apr;15(4):171-6, 179-80.