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

Primary Purpose

Insulin Resistance, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
chromium picolinate
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Insulin Resistance focused on measuring HIV, Treatment Experienced, Anti-Retroviral Agents, Antiretroviral Therapy, Highly Active, Picolinic acid, Dietary Supplements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State University of New York/General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Chromium Picolinate

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Improvement in insulin sensitivity

Secondary Outcome Measures

Full Information

First Posted
May 2, 2005
Last Updated
March 22, 2016
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
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1. Study Identification

Unique Protocol Identification Number
NCT00109746
Brief Title
Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults
Acronym
NT
Official Title
A Novel Therapy for Glucose Intolerance in HIV Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, HIV Infections
Keywords
HIV, Treatment Experienced, Anti-Retroviral Agents, Antiretroviral Therapy, Highly Active, Picolinic acid, Dietary Supplements

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chromium Picolinate
Arm Type
Active Comparator
Arm Description
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
Intervention Type
Dietary Supplement
Intervention Name(s)
chromium picolinate
Intervention Description
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
Primary Outcome Measure Information:
Title
Improvement in insulin sensitivity
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie C. Gelato, MD, PhD
Organizational Affiliation
State University of New York/General Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University of New York/General Clinical Research Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15807717
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.
Results Reference
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PubMed Identifier
15844072
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.
Results Reference
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PubMed Identifier
15844237
Citation
Taiwo BO. Insulin resistance, HIV infection, and anti-HIV therapies. AIDS Read. 2005 Apr;15(4):171-6, 179-80.
Results Reference
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Learn more about this trial

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

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