Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
47 participants
OBSERVATIONAL
2005-06-30
2012-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Chromium Picolinate
Subjects who are HIV+ and insulin resistant
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.
Placebo
HIV+ and insulin resistant
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Stony Brook University
OTHER
Responsible Party
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Marie Gelato
Distinguished Service Professor
Principal Investigators
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Marie C Gelato, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University School of Medicine Dept. Of Medicine/Endocrinology
Locations
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Stony Brook University Hospital GCRC
Stony Brook, New York, United States
Countries
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References
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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):239. doi: 10.4172/2155-6113.1000239.
Other Identifiers
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R21AT002499
Identifier Type: -
Identifier Source: org_study_id