Prediabetes, Vitamin D Deficiency
Conditions
Keywords
prediabetes, oral cholecalciferol
Brief summary
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.
Interventions
DRUGoral cholecalciferol + life style counselling
oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months
DRUGplacebo + life style counselling
Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \> 20 years * Impaired fasting glucose (IFG) - FPG 100-125 mg/dl * Impaired glucose tolerance((IGT)- 2hr PPG 140-199mg/dl OR * both ( IFG +IGT) * with or without Hb A1c -5.7-6.4 % WITH * Asymptomatic Vitamin D deficiency(\< 20ng/ml) or vitamin D in sufficiency(\< 32ng/ml)
Exclusion criteria
* Diabetes mellitus, * Base line 25(OH)D3 \> 32 ng/ml, * Symptomatic vitamin D deficiency, * Any medication within last month that could affect insulin secretion, insulin sensitivity , vitamin D and calcium metabolism * Chronic renal , hepatic ,malignant, intestinal or endocrine diseases * Febrile illness or infective morbidity in last 2 weeks, * Grossly deranged liver and kidney function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index) | Base line and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta % | Base line and 6 months | — |
| change in other insulin sensitivity indices | Base line and 6 months | QUICKI, HOMA 1-IR ,HOMA2- IR ,WBISI( Matsuda index),hepatic and muscle insulin sensitvity indices |
| Change in Hb A1c | Base line and 6 months | — |
| Change in fasting and post prandial blood glucose | 0,3, 6months | — |
Countries
India
Outcome results
None listed