Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Prediabetes
• Intervention / Treatment: Drug: oral cholecalciferol + life style counselling; Drug: placebo + life style counselling

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chandigarh(UT)
    • Chandigarh, Chandigarh(UT), India, 160012
      • PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Anil Bhansali, MD, DM, Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 19, 2011
• First Posted (Estimate): September 20, 2011

Study Record Updates

• Last Update Posted (Estimate): October 26, 2015
• Last Update Submitted That Met QC Criteria: October 23, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: prediabetes; oral cholecalciferol
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Hyperglycemia; Vitamin D Deficiency; Prediabetic State; Glucose Intolerance; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 0023051981