Role of replacing vitamin D in people who are deficient in vitamin-D and have a high risk of developing diabetes (prediabetes) in preventing the progression to diabetes

Not Applicable

Registration Number: CTRI/2011/091/000192

Lead Sponsor: Research Society for Study of Diabetes in India West Bengal Chapter

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Patients and their family members attending diabetic clinic, endocrine out patient department (OPD) services and health camps conducted by the department of Endocrinology & Metabolism, across the city of Kolkata, will be considered. Patients >30 years and <80 years of age will be considered. Family members of diabetic patients who gave consent would be screened by 75 gm OGTT with blood glucose measured at fasting, 1 hour and 2 hours post glucose.. Patients attending OPD with reports of impaired fasting glucose (IFG; 100-125mg/dl) and/or impaired glucose tolerance (IGT; 140-199mg/dl) would also undergo the same 75 gm OGTT and blood sugars would be measured at fasting, 1hour post glucose (1hPG) and 2hours post glucose (2hPG). Patients with fasting blood sugar between 100-125 mg/dl or 2 hour post meal blood sugar between 140-199mg/dl documented by 2 separate measurements over a week period would only be considered for the study.

Exclusion Criteria

Patients with history of diabetes or any history of oral hypoglycemic agents, insulin use would not be considered. Also patients with associated disorders like primary hyperparathyroidism, chronic kidney disease, liver disease, any chronic illness, malignancy, chronic drug use like anti-epileptic agents, oral contraceptive pills, steroids which are likely to interfere with vitamin-D metabolism will be excluded. Patients with pregnancy would be excluded. Treated patients of hypothyroidism who are clinically and biochemically euthyroid will be considered for the study. Patients with history of calcium or vitamin-D supplementation would also be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary End-point: <br/ ><br>1) Progression of prediabetes to overt diabetes <br/ ><br>(Diabetes defined as Fasting blood glucose 125mg/dl and/or 2 hour post prandial/post 75 gram glucose blood sugar 199mg/dl) <br/ ><br>2) Reversal to normoglycemia (defined as fasting blood glucose100mg/dl and 2h post 75 gram glucose blood glucose 140mg/dl)Timepoint: We plan to follow up all patients 3 monthly from a minimum of 1 year to a maximum of 5 years

Secondary Outcome Measures