Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398853
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2006-11-09
Brief Title:
Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
Chromium and Insulin Action
Status:
COMPLETED
Status Verified Date:
2016-04
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 effect of Chromium to improve glucose levels in diabetes is controversial The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 diabetes with chromium picolinate and assessing the effect of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps
Detailed Description:
Detailed Description
The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention However alternative strategies eg nutritional supplementation with over-the-counter agents are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider Unfortunately considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports As such there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities
One supplement that has attracted considerable clinical interest is chromium Cr However routine use of Cr in subjects with diabetes is not currently recommended In part the controversy surrounding Cr supplementation stems from the lack of definitive randomized trials the lack of gold standard techniques to assess glucose metabolism in the studies reported the use of differing doses and formulation and the study of heterogeneous study populations As such conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning Cr supplementation In order to provide a comprehensive clinical evaluation of Cr we conducted a randomized double-blinded placebo-controlled trial in subjects with Type 2 diabetes Individuals had baseline measures consisting of oral glucose tolerance testing body fat and adiposity assessed and then used established techniques to assess insulin sensitivity with hyperinsulinemic-euglycemic clamps Individuals were evaluated for 6 months at which time repeat testing was done
The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention However alternative strategies eg nutritional supplementation with over-the-counter agents are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider Unfortunately considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports As such there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities
One supplement that has attracted considerable clinical interest is chromium Cr However routine use of Cr in subjects with diabetes is not currently recommended In part the controversy surrounding Cr supplementation stems from the lack of definitive randomized trials the lack of gold standard techniques to assess glucose metabolism in the studies reported the use of differing doses and formulation and the study of heterogeneous study populations As such conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning Cr supplementation In order to provide a comprehensive clinical evaluation of Cr we conducted a randomized double-blinded placebo-controlled trial in subjects with Type 2 diabetes Individuals had baseline measures consisting of oral glucose tolerance testing body fat and adiposity assessed and then used established techniques to assess insulin sensitivity with hyperinsulinemic-euglycemic clamps Individuals were evaluated for 6 months at which time repeat testing was done
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