Novel Therapy for Glucose Intolerance in HIV Disease
|ClinicalTrials.gov Identifier: NCT02006914|
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : December 10, 2013
|Condition or disease||Intervention/treatment|
|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|
|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|
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
- 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
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|