A Double Blind Randomized Control Trial to Study the Effect of Vitamin D Supplementation on Peripheral Insulin Sensitivity in Centrally Obese Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Oral Glucose Insulin Sensitivity (OGIS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •≥35 years of age
- •Waist circumference ≥78 cm
排除标准
- •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
结局指标
主要结局
Oral Glucose Insulin Sensitivity (OGIS)
次要结局
- ApoA1
- ApoB
- Blood Pressure
- Lipid profile
- CRP
研究者
Dr Jitender Nagpal
Dr Jitender Nagpal
Sitaram Bhartia Institute of Science and Research
