- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01508481
Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes
October 5, 2012 updated by: Soo Lim, Seoul National University Bundang Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seongnam, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Diabetes high risk group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of diabetes
Time Frame: 5 years
|
Incidence of diabetes defined by American Diabetes Association criteria
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5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pancreatic beta cell function
Time Frame: 5 years
|
Pancreatic beta cell function assessed by homeostasis model
|
5 years
|
Insulin resistance
Time Frame: 5 years
|
Insulin resistance assessed by homeostasis model
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
January 5, 2012
First Submitted That Met QC Criteria
January 11, 2012
First Posted (Estimate)
January 12, 2012
Study Record Updates
Last Update Posted (Estimate)
October 10, 2012
Last Update Submitted That Met QC Criteria
October 5, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VitaminD_T2DM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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