Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067626
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2003-08-25
Brief Title:
Chromium Effects on Insulin and Vascular Function in People at Risk for Diabetes
Sponsor:
Griffin Hospital
Organization:
Griffin Hospital
Study Overview
Official Title:
Chromium Effects on Insulin and Vascular Function in People at Risk for Diabetes
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the effects of Chromium on glucose tolerance and endothelial function in people at risk for type II diabetes
Detailed Description:
Impaired glucose tolerance IGT impaired fasting glucose IFG and insulin resistance IR are precursors to type II diabetes mellitus DM and its sequelae and are cardiac risk factors in their own right The worsening epidemic of DM in the US along with the increasing prevalence of obesity insulin resistance and IGT render the identification of promising interventions for these states a matter of some urgency While lifestyle interventions based on dietary pattern and physical activity can delay or prevent the onset of diabetes and reduce cardiovascular risk adherence at the population level is severely limiting Pharmacotherapy offers promise for diabetes prevention but with associated high costs unacceptability to many patients and potential toxicity In this context the potential role of chromium Cr an insulin co-factor in IGT is of great interest Chromium use is widespread but evidence of any therapeutic effect is limited
Proposed therefore is a randomized double-blind placebo controlled pilot trial conducted at the Yale Prevention Research Center to investigate the effects of daily Cr for 6 months at two dose levels on serum measures of glucose tolerance and on endothelial function in adults with IGT IFG and IR A modified crossover design will allow for paired and unpaired analyses including comparison of both 500 mcg and 1000 mcg of Cr daily to placebo comparison between 500 mcg and 1000 mcg of chromium and evaluation of Cr washout time The study is powered to detect a clinically meaningful effect of Cr supplementation at either dose on glucose control and to compare the two doses for equivalence The study will investigate effects of Cr on both measures of glucose tolerance glucose insulin OGTT and brachial artery endothelial function thus combining serum measures with a physiologic test of Cr effects on the vasculature
The proposed study will generate much needed data regarding the efficacy of Cr in those at risk for type II diabetes and offers the promise of guiding practice as well as directing future study By contributing to knowledge related to potential diabetes prevention strategies this study addresses one of the more pressing public health issues in the US today Risk to human subjects in this study is a minor increment over minimal due to the administration of nitroglycerin as a control in BARS testing
Proposed therefore is a randomized double-blind placebo controlled pilot trial conducted at the Yale Prevention Research Center to investigate the effects of daily Cr for 6 months at two dose levels on serum measures of glucose tolerance and on endothelial function in adults with IGT IFG and IR A modified crossover design will allow for paired and unpaired analyses including comparison of both 500 mcg and 1000 mcg of Cr daily to placebo comparison between 500 mcg and 1000 mcg of chromium and evaluation of Cr washout time The study is powered to detect a clinically meaningful effect of Cr supplementation at either dose on glucose control and to compare the two doses for equivalence The study will investigate effects of Cr on both measures of glucose tolerance glucose insulin OGTT and brachial artery endothelial function thus combining serum measures with a physiologic test of Cr effects on the vasculature
The proposed study will generate much needed data regarding the efficacy of Cr in those at risk for type II diabetes and offers the promise of guiding practice as well as directing future study By contributing to knowledge related to potential diabetes prevention strategies this study addresses one of the more pressing public health issues in the US today Risk to human subjects in this study is a minor increment over minimal due to the administration of nitroglycerin as a control in BARS testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT001332 | NIH | None | httpsreporternihgovquickSearchR21AT001332 |