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Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

This study is currently recruiting participants.
Verified December 2011 by Postgraduate Institute of Medical Education and Research
Sponsor:
Information provided by (Responsible Party):
Anil Bhansali, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01436916
First received: September 13, 2011
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Prediabetes
Vitamin D Deficiency
 Drug: oral cholecalciferol + life style counselling
Drug: placebo + life style counselling
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index) [ Time Frame: Base line and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta % [ Time Frame: Base line and 6 months ] [ Designated as safety issue: No ]
  • change in other insulin sensitivity indices [ Time Frame: Base line and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in fasting and post prandial blood glucose [ Time Frame: 0,3, 6months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436916

Contacts
Contact: Anil Bhansali, MD, DM 0091-172-2756581 anilbhansali_endocrine@rediffmail.com
Contact: Prathosh Gangadhar, MD, DNB 0091-88472487119 prathosh@yahoo.com

Locations
India
PGIMER Recruiting
Chandigarh, Chandigarh(UT), India, 160012
Contact: Anil Bhansali, MD,DM     0091-172-2756581     anilbhansali_endocrine@rediffmail.com    
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Anil Bhansali, MD, DM PGIMER
  More Information

No publications provided

Responsible Party: Anil Bhansali, professor and head of the department of Endocrinology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01436916     History of Changes
Other Study ID Numbers: 0023051981
Study First Received: September 13, 2011
Last Updated: December 6, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
prediabetes
oral cholecalciferol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vitamin D Deficiency
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
 Malnutrition
Nutrition Disorders
Hyperglycemia
Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 17, 2013