A Trial to Study the Effect of Vitamin D Supplementation on Glucose and Insulin Metabolism in Centrally Obese Men

May 31, 2013 updated by: Dr Jitender Nagpal, Sitaram Bhartia Institute of Science and Research

A Double Blind Randomized Control Trial to Study the Effect of Vitamin D Supplementation on Peripheral Insulin Sensitivity in Centrally Obese Men

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110016
        • Sitaram Bhartia Institute of Science and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Oral Glucose Insulin Sensitivity (OGIS)

Secondary Outcome Measures

Outcome Measure
Lipid profile
CRP
Blood Pressure
ApoA1
ApoB

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sitaram Bhartia Institute of Science and Research

Investigators

  • Principal Investigator: Jitendra N Pande, MD, Sitaram Bhartia Institute of Science and Research
  • Principal Investigator: Jitender Nagpal, MD, Sitaram Bhartia Institute of Science and Research
  • Study Chair: Anupama Singh, MD, Sitaram Bhartia Institute of Science and Research
  • Study Director: Abhishek Bhartia, ME, Sitaram Bhartia Institute of Science and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBISR/2006/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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