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NCT Number: NCT01436916

Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

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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Key information

Conditions

PreDiabetes Avitaminosis Deficiency Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Prediabetic State Vitamin D Deficiency

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PGIMER

Chandigarh, Chandigarh(UT), 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral cholecalciferol + life style counselling

Drug

oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months

placebo + life style counselling

Drug

Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months

Primary outcomes

  1. Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)

    Time frame: Base line and 6 months

Secondary outcomes

  1. change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta %

    Time frame: Base line and 6 months

  2. 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

  3. Change in Hb A1c

    Time frame: Base line and 6 months

  4. Change in fasting and post prandial blood glucose

    Time frame: 0,3, 6months

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 20, 2011
Registry last updated
Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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