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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
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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

Groups and Cohorts
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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
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Primary Outcome Measures :
  1. 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:

  1. positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
  2. diagnosis of cancer;
  3. acute illness of any sort, however, patients may be enrolled once they are stable;
  4. hemoglobin less than 11.0 gldl or hemodynamically unstable;
  5. creatinine greater than or equal to 1.5 mgldl;
  6. liver dysfunction as evidenced by elevations in transaminases 2-fold higher than upper limit of normal;
  7. use of certain medications within the past month (e.g., glucocorticoids).
  8. untreated hypertension (systolic BP > 150 mmHG, diastolic BP>100 mmHG);
  9. patients with diabetes mellitus
  10. hypogonadism
  11. abnormal thyroid function (serum T'4 < 4 or > 12; TSH < 0.35 or > 5.5)
  12. 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).
  13. CD4 counts below 300
  14. 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
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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
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Publications of Results:

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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
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
 RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chromium
Picolinic acid
Trace Elements
Micronutrients
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action