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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral cholecalciferol + lifestyle counselling | Active Comparator | will receive Oral cholecalciferol |
|
| Placebo + lifestyle counselling | Placebo Comparator | will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral cholecalciferol + life style counselling | Drug | oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index) | Base line and 6 months |
| 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 |
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Inclusion Criteria:
OR
WITH
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Bhansali, MD, DM | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER | Chandigarh | Chandigarh(UT) | 160012 | India |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| placebo + life style counselling | Drug | Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |