Diabetes Mellitus, Non-Insulin-Dependent, Obesity
Conditions
Keywords
Vitamin D, Diabetes, Insulin sensitivity, Obesity
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.
Interventions
DRUGVitamin D
Sponsors
Sitaram Bhartia Institute of Science and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
35 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral Glucose Insulin Sensitivity (OGIS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile | — |
| CRP | — |
| ApoA1 | — |
| ApoB | — |
| Blood Pressure | — |
Countries
India
Outcome results
None listed