- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00109746
Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults (NT)
A Novel Therapy for Glucose Intolerance in HIV Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- State University of New York/General Clinical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
No Intervention: Placebo
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in insulin sensitivity
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marie C. Gelato, MD, PhD, State University of New York/General Clinical Research Center
Publications and helpful links
General Publications
- 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.
- 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.
- Taiwo BO. Insulin resistance, HIV infection, and anti-HIV therapies. AIDS Read. 2005 Apr;15(4):171-6, 179-80.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21 AT002499-01A1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on chromium picolinate
-
University of North Carolina, Chapel HillNational Alliance for Research on Schizophrenia and DepressionCompletedBinge Eating Disorder
-
Bastyr UniversityTerminated
-
Stony Brook UniversityCompleted
-
Pennington Biomedical Research CenterCompleted
-
Stony Brook UniversityCompleted
-
National Center for Complementary and Integrative...CompletedMetabolic Diseases | Obesity | Insulin Resistance | Prediabetic State | Metabolic Syndrome XUnited States
-
Pennington Biomedical Research CenterNutrition 21, Inc.Completed
-
Stoffwechselzentrum Rhein - PfalzCompletedType 2 Diabetes | PrediabetesGermany
-
DoubleGood ABLund UniversityCompleted
-
Pennington Biomedical Research CenterCompletedType 2 DiabetesUnited States