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临床试验/NCT01876563
NCT01876563Unknown4 期

the Effect of Vitamin D on the Serum Thioredoxin, TBP-2, Thioredoxin Reductase, Gene Expression of TBP-2 in Patients With Type II Diabetes

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
4 期
入组人数
30
试验地点
1
主要终点
serum total cholesterol

研究概览

简要总结

The aim of this study is the comparision between the effects of vitamin D or placebo supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase activity in patients with type 2 diabetes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • literate, willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention -

排除标准

  • people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers

结局指标

主要结局

serum total cholesterol

时间窗: change from baseline at 2 months

serum HDL cholesterol

时间窗: change from baseline at 2 months

serum triglycerides level

时间窗: change from baseline at 2 months

fasting plasma glucose

时间窗: change from baseline at 2 months

serum LDL cholesterol

时间窗: change from baseline at 2 months

complete blood count (CBC)

时间窗: change from baseline at 2 months

HbA1c

时间窗: change from baseline at 2 months

serum insulin

时间窗: change from baseline at 2 months

serum calcidiol

时间窗: change from baseline at 2 months

thioredoxin

时间窗: change from baseline at 2 months

thioredoxin binding protein 2 (TBP-2)

时间窗: change from baseline at 2 months

erytrocyte thioredoxin reductase

时间窗: change from baseline at 2 months

次要结局

  • GENE EXPRESSION OF TBP-2(change from baseline at 2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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