We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults (NT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00109746
Recruitment Status : Completed
First Posted : May 3, 2005
Last Update Posted : March 23, 2016
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Marie Gelato, Stony Brook University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Insulin Resistance HIV Infections Dietary Supplement: chromium picolinate Phase 1 Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Chromium Picolinate
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.
No Intervention: Placebo
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Improvement in insulin sensitivity [ Time Frame: 8 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, New York
State University of New York/General Clinical Research Center
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
Layout table for investigator information
Principal Investigator: Marie C. Gelato, MD, PhD State University of New York/General Clinical Research Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
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
Keywords provided by Marie Gelato, Stony Brook University:
HIV
Treatment Experienced
Anti-Retroviral Agents
 Antiretroviral Therapy, Highly Active
Picolinic acid
Dietary Supplements
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Chromium
Picolinic acid
Trace Elements
 Micronutrients
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action