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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
511
20.000 IU cholecalciferol per week for 5 years versus placebo
Placebo capsule once a week, identical to cholecalciferol capsule
University of Tromso
Tromsø, Norway
development of diabetes type 2
Time frame: 5 years
change in glucose metabolism
Time frame: 5 years
change in lipid status
Time frame: 5 years
change in mood
Time frame: 5 years
change in BMD hip
Time frame: 5 years
change in intima media thickness carotid artery
Time frame: 5 years
change in frequency of infections
Time frame: 5 years
change in blood pressure
Time frame: 5 years
Change in Insulin sensitivity
Time frame: 5 years
change in HbA1c
Time frame: 5 years
change in weight
Time frame: 5 years
change in telomer length
Time frame: 5 years
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