Novel Therapy for Glucose Intolerance in HIV Disease
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Novel Therapy for Glucose Intolerance in HIV Disease|
- Chromium Picolinate supplementation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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
|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
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
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|