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
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Condition or disease | Intervention/treatment |
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Insulin Resistance | Dietary Supplement: Chromium Picolinate |
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 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 |
Group/Cohort | Intervention/treatment |
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Chromium Picolinate
Subjects who are HIV+ and insulin resistant
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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
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- 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

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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 |
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.

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
United States, New York | |
Stony Brook University Hospital GCRC | |
Stony Brook, New York, United States, 11794 |
Principal Investigator: | Marie C Gelato, MD, PhD | Stony Brook University School of Medicine Dept. Of Medicine/Endocrinology |
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 |
Insulin resistance HIV disease chromium picolinate |
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 |