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

Sponsor

Sitaram Bhartia Institute of Science and Research (Other)

Overall Status

Completed

CT.gov ID

NCT00347542

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Non-Insulin-Dependent Obesity	Drug: Vitamin D	N/A

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

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 Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

Oral Glucose Insulin Sensitivity (OGIS) []

Secondary Outcome Measures

Lipid profile []
CRP []
ApoA1 []
ApoB []
Blood Pressure []

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sitaram Bhartia Institute of Science and Research	New Delhi	Delhi	India	110016

Sponsors and Collaborators

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