Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D deficiency is also high i.e. 78-96% in different groups of population in north India. Observational studies find association between low Vitamin D status and type 2 diabetes mellitus. Prediabetes is a condition that progress to diabetes at a rate of 6-10% per year .There is mechanistic support that vitamin D may influence both insulin secretion and insulin sensitivity and subsequently T2DM incidence. In general, cross-sectional and prospective studies support the role of vitamin D in the prevention of T2DM. This study will be a single blind randomized placebo controlled trial to study the effect of oral cholecalciferol in insulin sensitivity and secretion in adults with prediabetes who are also vitamin D insufficient.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > 20 years
- •Impaired fasting glucose (IFG) - FPG 100-125 mg/dl
- •Impaired glucose tolerance((IGT)- 2hr PPG 140-199mg/dl
- •both ( IFG +IGT)
- •with or without Hb A1c -5.7-6.4 %
- •Asymptomatic Vitamin D deficiency(< 20ng/ml) or vitamin D in sufficiency(< 32ng/ml)
排除标准
- •Diabetes mellitus,
- •Base line 25(OH)D3 > 32 ng/ml,
- •Symptomatic vitamin D deficiency,
- •Any medication within last month that could affect insulin secretion, insulin sensitivity , vitamin D and calcium metabolism
- •Chronic renal , hepatic ,malignant, intestinal or endocrine diseases
- •Febrile illness or infective morbidity in last 2 weeks,
- •Grossly deranged liver and kidney function
研究组 & 干预措施
oral cholecalciferol + lifestyle counselling
will receive Oral cholecalciferol
干预措施: oral cholecalciferol + life style counselling (Drug)
Placebo + lifestyle counselling
will receive placebo
干预措施: placebo + life style counselling (Drug)
结局指标
主要结局
Change in insulin sensitivity using OGIS (oral glucose insulin sensitivity index)
时间窗: Base line and 6 months
次要结局
- change in other insulin sensitivity indices(Base line and 6 months)
- Change in Hb A1c(Base line and 6 months)
- Change in fasting and post prandial blood glucose(0,3, 6months)
- change in indices of insulin secretion using HOMA1-beta% and HOMA2-beta %(Base line and 6 months)
研究者
Anil Bhansali
professor and head of the department of Endocrinology
Post Graduate Institute of Medical Education and Research, Chandigarh