Clinical trial NCT00347542: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Obesity
Keywords: Vitamin D
Diabetes
Insulin sensitivity
Obesity
Lead sponsor: Sitaram Bhartia Institute of Science and Research
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 100
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Oral Glucose Insulin Sensitivity (OGIS)
Secondary outcomes:
measure: Lipid profile
measure: CRP
measure: ApoA1
measure: ApoB
measure: Blood Pressure
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sitaram Bhartia Institute of Science and Research
state: Delhi
Study officials:
affiliation: Sitaram Bhartia Institute of Science and Research
name: Jitendra N Pande, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sitaram Bhartia Institute of Science and Research
name: Jitender Nagpal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sitaram Bhartia Institute of Science and Research
name: Anupama Singh, MD
role: STUDY_CHAIR
affiliation: Sitaram Bhartia Institute of Science and Research
name: Abhishek Bhartia, ME
role: STUDY_DIRECTOR
References: