Novel Therapy for Glucose Intolerance in HIV Disease
Stony Brook University
Information provided by (Responsible Party)
Marie Gelato, Stony Brook University
First received: August 11, 2011
Last updated: December 5, 2013
Last Verified: December 2013
History of Changes
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.
Dietary Supplement : Chromium Picolinate
Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Novel Therapy for Glucose Intolerance in HIV Disease|
Further study details as provided by Marie Gelato, Stony Brook University:
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
|Study Start Date:||June 2005|
|Study Completion Date:||April 2012|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Subjects who are HIV+ and insulin resistant
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
HIV+ and insulin resistant
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
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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
Study PopulationAnyone with a positive diagnosis of HIV disease.
- Age > 18 years and a diagnosis of HIV+ andlor AlDS made by standard CDC criteria.
~#o1~ positive pregnancy test (all women must have a negative pregnancy test before
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02006914
Locations Show More
|United States, New York|
|Stony Brook University Hospital GCRC|
|Stony Brook, New York, United States, 11794|
Sponsors and CollaboratorsStony Brook University
|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 History of Changes|
|Other Study ID Numbers:||R21AT002499|
|Study First Received:||August 11, 2011|
|Last Updated:||December 5, 2013|
Keywords provided by Marie Gelato, Stony Brook University:Insulin resistance
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.