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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Jitender Nagpal, Sitaram Bhartia Institute of Science and Research
ClinicalTrials.gov Identifier:
NCT00347542
First received: June 30, 2006
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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 Intervention
Diabetes Mellitus, Non-Insulin-Dependent
Obesity
Drug: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Sitaram Bhartia Institute of Science and Research:

Primary Outcome Measures:
  • Oral Glucose Insulin Sensitivity (OGIS)

Secondary Outcome Measures:
  • Lipid profile
  • CRP
  • ApoA1
  • ApoB
  • Blood Pressure

Estimated Enrollment: 100
Study Start Date: July 2006
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347542

Locations
India
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
  More Information

No publications provided

Responsible Party: Dr Jitender Nagpal, Sitaram Bhartia Institute of Science and Research
ClinicalTrials.gov Identifier: NCT00347542     History of Changes
Other Study ID Numbers: SBISR/2006/03
Study First Received: June 30, 2006
Last Updated: May 31, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Sitaram Bhartia Institute of Science and Research:
Vitamin D
Diabetes
Insulin sensitivity
Obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin
Vitamins
Vitamin D
Ergocalciferols
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014