Novel Therapy for Glucose Intolerance in HIV Disease

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ClinicalTrials.gov Identifier: NCT02006914

Recruitment Status : Completed

First Posted : December 10, 2013

Last Update Posted : December 10, 2013

Sponsor:

Information provided by (Responsible Party):

Marie Gelato, Stony Brook University

Study Description

Brief Summary:

This research is to investigate the nutritional supplement chromium picolinate. The investigators are testing to see how effective this supplement is in treating insulin resistance associated with HIV disease.

Condition or disease	Intervention/treatment
Insulin Resistance	Dietary Supplement: Chromium Picolinate

Detailed Description:

This study will test the hypothesis that chromium picolinate improves insulin-stimulated glucose uptake by increasing the insulin receptor-mediated tyrosine phosphorylation of insulin receptor substrate-1, resulting in increased association with phosphatidylinositol 3-kinase.

Specific Aim 1 will assess quantitative improvements in insulin-mediated glucose disposal in a placebo-controlled clinical trial of chromium supplementation with 1000mpg (19.2 pmol) of chromium as chromium picolinate, overa two-month course of therapy. The investigators have shown that the insulin resistance (i.e. the inability of insulin to stimulate glucose uptake into peripheral tissues like muscle) in patients with HIV disease is associated with a defect in the insulin-signaling pathway leading from the insulin receptor, through phosphatidylinositol 3-kinase(PI 3-K, Figure 5). A similar defect in intracellular signaling has also been reported in patients with type 2 diabetes mellitus ):15-171. The cellular mechanism of improved insulin sensitivity with chromium supplementation will be determined in Specific Aim 2.

Specific Aim 2 will assess the effect of chromium supplementation on the insulin-stimulated activity of insulin receptor substrate-I-associated phosphatidylinositol 3-kinase in biopsies of muscle and fat tissue. This aim will also test the hypothesis that these physiological effects of chromium are mediated by alterations in the activity of insulin signaling. Understanding this mechanism may facilitate the design of even more effective strategies for improving insulin sensitivity.

Study Design

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Study Type :	Observational
Actual Enrollment :	47 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Novel Therapy for Glucose Intolerance in HIV Disease
Study Start Date :	June 2005
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Chromium Chromium picolinate Zinc picolinate

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Chromium Picolinate Subjects who are HIV+ and insulin resistant	Dietary Supplement: Chromium Picolinate Subjects will be asked to take chromium picolinate; 2 tablets per day, 1000 mcg or a placebo for a total of 8 weeks. Other Name: Chromax
Placebo HIV+ and insulin resistant

Outcome Measures

Primary Outcome Measures :

Chromium Picolinate supplementation [ Time Frame: 8 weeks ]
Hypothesis that chromium picolinate improved insulin-stimulated glucose uptake by increasing the insulin receptor-mediated tyrosine phosphorylation of insulin receptor substrate-1, resulting in increased association with phosphatidylinositol 3-kinase. There was a significant negative correlation between the fasting glucose levels and the insulin sensitivity.

Biospecimen Retention: Samples With DNA

Fat and muscle biopsy samples

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Anyone with a positive diagnosis of HIV disease.

Criteria

Inclusion Criteria:

Age > 18 years and a diagnosis of HIV+ andlor AlDS made by standard CDC criteria.

Exclusion Criteria:

positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
diagnosis of cancer;
acute illness of any sort, however, patients may be enrolled once they are stable;
hemoglobin less than 11.0 gldl or hemodynamically unstable;
creatinine greater than or equal to 1.5 mgldl;
liver dysfunction as evidenced by elevations in transaminases 2-fold higher than upper limit of normal;
use of certain medications within the past month (e.g., glucocorticoids).
untreated hypertension (systolic BP > 150 mmHG, diastolic BP>100 mmHG);
patients with diabetes mellitus
hypogonadism
abnormal thyroid function (serum T'4 < 4 or > 12; TSH < 0.35 or > 5.5)
hepatitis C infection (if patients have had prior therapy and are now stable with no evidence of active infection they will be included. This will depend upon documentation from primary care giver).
CD4 counts below 300
viral load greater than 35,000.

Exclusion criteria (13) and (14) are added because the protocol requires that subjects be on a stable anti-retroviral regime for 3 months prior to study and 2 months on study. These criteria will make it less likely that anti-retroviral therapies will be switched in this subject population who are doing well.

Contacts and Locations

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): NCT02006914

Locations

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United States, New York
Stony Brook University Hospital GCRC
Stony Brook, New York, United States, 11794

Sponsors and Collaborators

Stony Brook University

Investigators

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Principal Investigator:	Marie C Gelato, MD, PhD	Stony Brook University School of Medicine Dept. Of Medicine/Endocrinology

More Information

Publications of Results:

Stein SA, Mc Nurlan M, Phillips BT, Messina C, Mynarcik D, Gelato M. Chromium Therapy for Insulin Resistance Associated with HIV-Disease. J AIDS Clin Res. 2013 Sep 7;4(9). pii: 239.

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Responsible Party:	Marie Gelato, Distinguished Service Professor, Stony Brook University
ClinicalTrials.gov Identifier:	NCT02006914
Other Study ID Numbers:	R21AT002499
First Posted:	December 10, 2013 Key Record Dates
Last Update Posted:	December 10, 2013
Last Verified:	December 2013

Keywords provided by Marie Gelato, Stony Brook University:


Insulin resistance HIV disease chromium picolinate

Additional relevant MeSH terms:

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Acquired Immunodeficiency Syndrome HIV Infections Insulin Resistance Glucose Intolerance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Hyperglycemia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Chromium Picolinic acid Trace Elements Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Iron Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action

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