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Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01508481
First received: January 5, 2012
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Incidence of diabetes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Incidence of diabetes defined by American Diabetes Association criteria


Secondary Outcome Measures:
  • Pancreatic beta cell function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Pancreatic beta cell function assessed by homeostasis model

  • Insulin resistance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Insulin resistance assessed by homeostasis model


Biospecimen Retention:   None Retained

Blood sample was collected at the baseline.


Enrollment: 1500
Study Start Date: January 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes high risk group

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508481

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Soo Lim, MD, PHD Seoul National University Bundang Hospital
  More Information

No publications provided by Seoul National University Bundang Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Soo Lim, Principal Investigator, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01508481     History of Changes
Other Study ID Numbers: VitaminD_T2DM
Study First Received: January 5, 2012
Last Updated: October 5, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
Vitamin D
Diabetes
pancreas beta cell function
insulin resistance
Deficiency of Vitamin D3

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin D
Ergocalciferols
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013