Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D deficiency is also high i.e. 78-96% in different groups of population in north India. Observational studies find association between low Vitamin D status and type 2 diabetes mellitus. Prediabetes is a condition that progress to diabetes at a rate of 6-10% per year .There is mechanistic support that vitamin D may influence both insulin secretion and insulin sensitivity and subsequently T2DM incidence. In general, cross-sectional and prospective studies support the role of vitamin D in the prevention of T2DM. This study will be a single blind randomized placebo controlled trial to study the effect of oral cholecalciferol in insulin sensitivity and secretion in adults with prediabetes who are also vitamin D insufficient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
50
oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months
Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months
PGIMER
Chandigarh, Chandigarh(UT), India
Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)
Time frame: Base line and 6 months
change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta %
Time frame: Base line and 6 months
change in other insulin sensitivity indices
QUICKI, HOMA 1-IR ,HOMA2- IR ,WBISI( Matsuda index),hepatic and muscle insulin sensitvity indices
Time frame: Base line and 6 months
Change in Hb A1c
Time frame: Base line and 6 months
Change in fasting and post prandial blood glucose
Time frame: 0,3, 6months
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