Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT01508481
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Emerging evidence suggests that vitamin D \[25-hydroxyvitamin D; 25(OH)D\] may play a role in the etiology of type 2 diabetes. Vitamin D levels are lower in those with type 2 diabetes and impaired glucose tolerance (IGT) compared with those with normal glucose tolerance (NGT). In addition, a few prospective studies have shown a significant inverse association of baseline serum 25(OH)D with incident diabetes. To date, however, the exact mechanisms through which vitamin D affects diabetes risk are not yet fully known, particularly whether vitamin D plays a role in insulin resistance (IR) and/or b-cell dysfunction, the main pathophysiological disorders underlying type 2 diabetes. So, the investigators plan to examine the prospective associations of baseline vitamin D \[25-hydroxyvitamin D; 25(OH)D\] with insulin resistance (IR), b-cell function, and glucose homeostasis in subjects at risk for type 2 diabetes.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-12
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-05
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• one or more risk factors for diabetes, including:

  • obesity
  • hypertension
  • dislipidemia
  • a family history of diabetes

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Exclusion Criteria

• previous diagnosed diabetes
• vitamin D supplement.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of diabetes	5 years	Incidence of diabetes defined by American Diabetes Association criteria

Secondary Outcome Measures

Name	Time	Method
Insulin resistance	5 years	Insulin resistance assessed by homeostasis model
Pancreatic beta cell function	5 years	Pancreatic beta cell function assessed by homeostasis model

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of