Clinical Trial: Vitamin D in Minorities With Prediabetes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population

Brief Summary: Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.

Detailed Summary: Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people with diabetes. Minority populations (African-Americans and Latinos) are more likely to have both low levels of vitamin D and diabetes. This study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be randomized to either high doses of vitamin D or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. This study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin D and whether supplementing this vitamin may delay the development of diabetes.
Sponsor: Charles Drew University of Medicine and Science

Current Primary Outcome: Percent of Subjects Who Develop Diabetes [ Time Frame: one year ]

Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl


Original Primary Outcome: Percent of Subjects Who Develop Diabetes [ Time Frame: one year ]

Current Secondary Outcome: Disposition Index [ Time Frame: Baseline, 3, 6, 9, 12 months ]

Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better


Original Secondary Outcome: Disposition Index [ Time Frame: one year ]

Information By: Charles Drew University of Medicine and Science

Dates:
Date Received: April 6, 2009
Date Started: March 2009
Date Completion:
Last Updated: April 17, 2013
Last Verified: April 2013