Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

Phase 4

Completed

• Conditions: Prediabetes; Vitamin D Deficiency
• Interventions: Drug: placebo + life style counselling; Drug: oral cholecalciferol + life style counselling

• Registration Number: NCT01436916
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + lifestyle counselling	placebo + life style counselling	will receive placebo
oral cholecalciferol + lifestyle counselling	oral cholecalciferol + life style counselling	will receive Oral cholecalciferol

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)	Base line and 6 months

Secondary Outcome Measures

Name	Time	Method
change in other insulin sensitivity indices	Base line and 6 months	QUICKI, HOMA 1-IR ,HOMA2- IR ,WBISI( Matsuda index),hepatic and muscle insulin sensitvity indices
Change in Hb A1c	Base line and 6 months
Change in fasting and post prandial blood glucose	0,3, 6months
change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta %	Base line and 6 months

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, Chandigarh(UT), India