Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Center for Complementary and Integrative Health (NCCIH)

Collaborator
Office of Dietary Supplements (ODS)

Information provided by (Responsible Party)
Marie Gelato, Stony Brook University

ClinicalTrials.gov Identifier
NCT00109746

First received: May 2, 2005
Last updated: March 22, 2016
Last Verified: May 2013
History of Changes
Purpose

Purpose

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 Intervention Phase
Insulin Resistance
HIV Infections

Dietary Supplement : chromium picolinate
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Marie Gelato, Stony Brook University:

Primary Outcome Measures

  • Improvement in insulin sensitivity [ Time Frame: 8 weeks ]

Enrollment: 39
Study Start Date: November 2005
Study Completion Date: June 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109746

Locations

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

Principal Investigator: Marie C. Gelato, MD, PhD State University of New York/General Clinical Research Center
More Information

More Information


Responsible Party: Marie Gelato, Principal Investigator, Stony Brook University  
ClinicalTrials.gov Identifier: NCT00109746   History of Changes  
Other Study ID Numbers: R21 AT002499-01A1  
Study First Received: May 2, 2005  
Last Updated: March 22, 2016  

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:
HIV Infections
Insulin Resistance
Chromium
Picolinic acid

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.