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临床试验/NCT03138616
NCT03138616Unknown4 期

The Impacts of Vitamin D Supplementation on Glucose Metabolism in Chinese Women With Vitamin D Deficiency and Former Gestational Diabetes Mellitus:A Randomised Control Trial

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2016年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
180
试验地点
1
主要终点
Change in glucose metabolism

研究概览

简要总结

Vitamin D deficiency are related to insulin resistance and impaired beta-cell function.It is reported that the level of vitamin D is lower during pregnancy and postpartum in the women with Gestational Diabetes Mellitus. The investigators hypothesize that vitamin D supplementation to women after birth with previous gestational diabetes may improve glucose metabolism.

详细描述

Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance that is first identified during pregnancy, excluding diabetic patients diagnosed before pregnancy. GDM can not only have an adverse effect on the pregnant women and the developing fetus, but also can have long lasting effects after birth. GDM can elevates risks of abnormal glucose metabolism postpartum. Vitamin D deficiency has been shown to be associated with insulin resistance and impaired β-cell function. Our previous research also implied that the level of vitamin D is much lower in the women of impaired glucose regulation after birth with history of GDM. This prospective randomized, control clinical trial was designed to evaluate the effects of vitamin D administration on insulin resistance and β-cell function among women with vitamin D deficiency(25OHD <50 ng/mL)and previous GDM. Participants with vitamin D deficiency and previous GDM were divided into normal glucose regulation group(NGR) (n=90) and impaired glucose regulation group(IGR)(n=90) according to the oral glucose tolerance test (OGTT) around 42 days postpartum. And each group was further divided into intervention group and control group, Participants in the intervention group took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention. The control group only receive lifestyle intervention. This study aimed to evaluate the impact of vitamin D supplementation on insulin sensitivity, pancreatic β-cell function and markers of inflammation in Chinese women with former GDM and vitamin D insufficiency.

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
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • with previous GDM,40-50 days after birth -
  • with deficiency of vitamin D(25-(OH)D3<50nmol/L)

排除标准

  • type 1 diabetes,type 2 diabetes and other type of diabetes
  • server disfunction of liver and kidney(ALT >100U/L,Cr>132ummol/L)
  • with mental disease,sever anemia,sever infection,sever heart disease,now is taking asprin, immunosuppressive agent,Antiepileptic drugs
  • pregnancy or plan to pregnant in one year
  • can't understand the requirement of this study
  • disfunction of thyroid

研究组 & 干预措施

vitamin D intervention group(NGR)

Experimental

normal glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum.

took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention.

干预措施: vitamin D (Drug)

vitamin D intervention group(IGR)

Experimental

impaired glucose regulation group according to the oral glucose tolerance test (OGTT) around 42 days postpartum.

took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention.

干预措施: vitamin D (Drug)

结局指标

主要结局

Change in glucose metabolism

时间窗: 9 months

change in Insulin sensitivity index,insulin resistance,inflammatory factors

次要结局

  • change in Lipid metabolism(9 months)
  • change in metabolism of calcium and phosphorus(9 months)

研究者

发起方
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yufan Wang

Principal Investigator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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