Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

Study Overview
=================
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.

Official Title
-----------------
Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency

Conditions
-----------------
Prediabetes, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: oral cholecalciferol + life style counselling
* Drug: placebo + life style counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral cholecalciferol + lifestyle counselling<br>will receive Oral cholecalciferol | Drug: oral cholecalciferol + life style counselling<br>* oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months<br>|
| Placebo Comparator: Placebo + lifestyle counselling<br>will receive placebo | Drug: placebo + life style counselling<br>* Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index) |  | Base line and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta % |  | 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 | Base line and 6 months | 
| Change in Hb A1c |  | Base line and 6 months | 
| Change in fasting and post prandial blood glucose |  | 0,3, 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prediabetes, oral cholecalciferol