search
Back to results

Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

Primary Purpose

Prediabetes, Vitamin D Deficiency

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
oral cholecalciferol + life style counselling
placebo + life style counselling
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring prediabetes, oral cholecalciferol

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

oral cholecalciferol + lifestyle counselling

Placebo + lifestyle counselling

Arm Description

will receive Oral cholecalciferol

will receive placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2011
Last Updated
October 23, 2015
Sponsor
Postgraduate Institute of Medical Education and Research
search

1. Study Identification

Unique Protocol Identification Number
NCT01436916
Brief Title
Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus
Official Title
Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Vitamin D Deficiency
Keywords
prediabetes, oral cholecalciferol

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral cholecalciferol + lifestyle counselling
Arm Type
Active Comparator
Arm Description
will receive Oral cholecalciferol
Arm Title
Placebo + lifestyle counselling
Arm Type
Placebo Comparator
Arm Description
will receive placebo
Intervention Type
Drug
Intervention Name(s)
oral cholecalciferol + life style counselling
Intervention Description
oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months
Intervention Type
Drug
Intervention Name(s)
placebo + life style counselling
Intervention Description
Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months
Primary Outcome Measure Information:
Title
Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)
Time Frame
Base line and 6 months
Secondary Outcome Measure Information:
Title
change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta %
Time Frame
Base line and 6 months
Title
change in other insulin sensitivity indices
Description
QUICKI, HOMA 1-IR ,HOMA2- IR ,WBISI( Matsuda index),hepatic and muscle insulin sensitvity indices
Time Frame
Base line and 6 months
Title
Change in Hb A1c
Time Frame
Base line and 6 months
Title
Change in fasting and post prandial blood glucose
Time Frame
0,3, 6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Bhansali, MD, DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIMER
City
Chandigarh
State/Province
Chandigarh(UT)
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Learn more about this trial

Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

We'll reach out to this number within 24 hrs