Back to resultsA Trial to Study the Effect of Vitamin D Supplementation on Glucose and Insulin Metabolism in Centrally Obese Men
Primary Purpose
Diabetes Mellitus, Non-Insulin-Dependent, Obesity
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Non-Insulin-Dependent focused on measuring Vitamin D, Diabetes, Insulin sensitivity, Obesity
Eligibility Criteria
Inclusion Criteria: Male ≥35 years of age Waist circumference ≥78 cm Exclusion Criteria: Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication BP>140/90 or on anti-hypertensive medication Receiving Vitamin D or calcium supplementation Chronic disease-renal/hepatic/malignancy/gastrointestinal On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism Febrile illness or infective morbidity in the past 10 days Past history of nephrolithiasis
Sites / Locations
- Sitaram Bhartia Institute of Science and Research
Outcomes
Primary Outcome Measures
Oral Glucose Insulin Sensitivity (OGIS)
Secondary Outcome Measures
Lipid profile
CRP
ApoA1
ApoB
Blood Pressure
Full Information
NCT ID
NCT00347542
First Posted
June 30, 2006
Last Updated
May 31, 2013
Sponsor
Sitaram Bhartia Institute of Science and Research
1. Study Identification
Unique Protocol Identification Number
NCT00347542
Brief Title
A Trial to Study the Effect of Vitamin D Supplementation on Glucose and Insulin Metabolism in Centrally Obese Men
Official Title
A Double Blind Randomized Control Trial to Study the Effect of Vitamin D Supplementation on Peripheral Insulin Sensitivity in Centrally Obese Men
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sitaram Bhartia Institute of Science and Research
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the change in glucose and insulin metabolism(early markers for development of diabetes) after 6 weeks of weekly Vitamin D supplementation. As vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we will also be measuring the changes in these variables.
Detailed Description
Accumulating evidence suggests that serum Vitamin D levels may be inversely related to the prevalence of diabetes, to the concentration of glucose , insulin resistance and metabolic syndrome.These results have been replicated in patients at risk for diabetes with documentation of impairment in insulin secretion in Vitamin D deficient subjects. Therefore, vitamin D could be implicated in the pathogenesis of type 2 diabetes, by affecting either insulin sensitivity or ß cell function, or both. However, there is paucity of literature on the effect of Vitamin D supplementation on insulin resistance or glucose metabolism. As vitamin D has been reported to be associated with lipid levels, CRP and blood pressure , we will also be measuring the changes in these variables.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent, Obesity
Keywords
Vitamin D, Diabetes, Insulin sensitivity, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Primary Outcome Measure Information:
Title
Oral Glucose Insulin Sensitivity (OGIS)
Secondary Outcome Measure Information:
Title
Lipid profile
Title
CRP
Title
ApoA1
Title
ApoB
Title
Blood Pressure
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male
≥35 years of age
Waist circumference ≥78 cm
Exclusion Criteria:
Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication
BP>140/90 or on anti-hypertensive medication
Receiving Vitamin D or calcium supplementation
Chronic disease-renal/hepatic/malignancy/gastrointestinal
On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
Febrile illness or infective morbidity in the past 10 days
Past history of nephrolithiasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jitendra N Pande, MD
Organizational Affiliation
Sitaram Bhartia Institute of Science and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jitender Nagpal, MD
Organizational Affiliation
Sitaram Bhartia Institute of Science and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anupama Singh, MD
Organizational Affiliation
Sitaram Bhartia Institute of Science and Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abhishek Bhartia, ME
Organizational Affiliation
Sitaram Bhartia Institute of Science and Research
Official's Role
Study Director
Facility Information:
Facility Name
Sitaram Bhartia Institute of Science and Research
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110016
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Trial to Study the Effect of Vitamin D Supplementation on Glucose and Insulin Metabolism in Centrally Obese Men
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