Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes
| Tracking Information | |||||
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| First Received Date ICMJE | January 5, 2012 | ||||
| Last Updated Date | October 5, 2012 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of diabetes [ Time Frame: 5 years ] [ Designated as safety issue: No ] Incidence of diabetes defined by American Diabetes Association criteria |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01508481 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes | ||||
| Official Title ICMJE | Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: None Retained Description: Blood sample was collected at the baseline. |
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| 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. |
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| Condition ICMJE | Type 2 Diabetes | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Diabetes high risk group | ||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1500 | ||||
| Completion Date | October 2012 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01508481 | ||||
| Other Study ID Numbers ICMJE | VitaminD_T2DM | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Soo Lim, Seoul National University Bundang Hospital | ||||
| Study Sponsor ICMJE | Seoul National University Bundang Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Seoul National University Bundang Hospital | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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