Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508481
• Other study ID #: VitaminD_T2DM
• Status: Completed
• Phase: N/A
• First received: January 5, 2012
• Last updated: October 5, 2012
• Start date: January 2007
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• one or more risk factors for diabetes, including:

• obesity

• hypertension

• dislipidemia

• a family history of diabetes

Exclusion Criteria:

• previous diagnosed diabetes

• vitamin D supplement.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of diabetes	Incidence of diabetes defined by American Diabetes Association criteria	5 years	No
Secondary	Pancreatic beta cell function	Pancreatic beta cell function assessed by homeostasis model	5 years	No
Secondary	Insulin resistance	Insulin resistance assessed by homeostasis model	5 years	No