Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

Overview

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.

Full Title of Study: “Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 2012

Interventions

  • Drug: oral cholecalciferol + life style counselling
    • oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months
  • Drug: placebo + life style counselling
    • Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months

Arms, Groups and Cohorts

  • Active Comparator: oral cholecalciferol + lifestyle counselling
    • will receive Oral cholecalciferol
  • Placebo Comparator: Placebo + lifestyle counselling
    • will receive placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)
    • Time Frame: Base line and 6 months

Secondary Measures

  • 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
    • Time Frame: Base line and 6 months
    • QUICKI, HOMA 1-IR ,HOMA2- IR ,WBISI( Matsuda index),hepatic and muscle insulin sensitvity indices
  • Change in Hb A1c
    • Time Frame: Base line and 6 months
  • Change in fasting and post prandial blood glucose
    • Time Frame: 0,3, 6months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Postgraduate Institute of Medical Education and Research
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anil Bhansali, professor and head of the department of Endocrinology – Postgraduate Institute of Medical Education and Research
  • Overall Official(s)
    • Anil Bhansali, MD, DM, Principal Investigator, PGIMER

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