Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes

NCT01508481 | Completed

• 1 other identifier: VitaminD_T2DM
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Vitamin D; Diabetes; pancreas beta cell function; insulin resistance; Deficiency of Vitamin D3

Outcome Measures

Primary Outcomes (1)

• Incidence of diabetes

  Incidence of diabetes defined by American Diabetes Association criteria

  5 years

Secondary Outcomes (2)

• Pancreatic beta cell function

  5 years

• Insulin resistance

  5 years

Study Arms (1)

Diabetes high risk group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants, aged over 30 years, are recruited from Korea, between January 2006 and December 2011. Participants are at high risk for type 2 diabetes, as they are recruited on the basis of the presence of one or more risk factors for diabetes, including obesity, hypertension, dislipidemia, and a family history of diabetes. Participants are contacted every 6 month after the baseline visit to update contact information and collect data on major health events. Participants are invited to return to the clinic examination centers after 3 years for follow-up assessments.

You may qualify if:

• one or more risk factors for diabetes, including:
• obesity
• hypertension
• dislipidemia
• a family history of diabetes

You may not qualify if:

• previous diagnosed diabetes
• vitamin D supplement.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

Related Publications (1)

• Lim S, Kim MJ, Choi SH, Shin CS, Park KS, Jang HC, Billings LK, Meigs JB. Association of vitamin D deficiency with incidence of type 2 diabetes in high-risk Asian subjects. Am J Clin Nutr. 2013 Mar;97(3):524-30. doi: 10.3945/ajcn.112.048496. Epub 2013 Jan 30.

  PMID: 23364011 DERIVED

Biospecimen

Retention: NONE RETAINED

Blood sample was collected at the baseline.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Soo Lim, MD, PHD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 12, 2012
• Study Start: January 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

KR (1)