University of Tromso
Tromsø, 9037, Norway
NCT Number: NCT00685594
The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.
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Notify Me21 year–80 year
All sexes
Interventional
Phase 2 / Phase 3
Tromsø, 9037, Norway
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20.000 IU cholecalciferol per week for 5 years versus placebo
Other names: vitamin D
Placebo capsule once a week, identical to cholecalciferol capsule
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 1 year
The response to oral glucose tolerance test (fasting and 2 h blood glucose, serum insulin, C-peptide, measures of insulin resistiance as well as metabolic parameters (lipids, blood pressure)) will be evaluated in the results at the 1-year visit in relation to genetic polymorphisms in the vitamin D system
University of Tromso
Other
Prevention of Type 2 Diabetes With Vitamin D Supplementation in Subjects With Reduced Glucose Tolerance Detected in the Tromso Study 2007/2008
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