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临床试验/NCT03651934
NCT03651934Unknown不适用

Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators

Peking Union Medical College Hospital0 个研究点目标入组 600 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
600
主要终点
Correlation between gestational diabetes-related gene monitoring results and glycosylated hemoglobin,fasting blood glucose, fasting insulin levels in vivo

研究概览

简要总结

The research plan is divided into two parts. The first part is the correlation study .It is planned to include women who prepare for pregnancy or in the early stages of pregnancy to carry out the detection of 25 loci SNP of 21 genes of 9 nutrients, to predict the nutritional abnormalities of 9 nutrients, and to determine the nutritional status of 9 nutrients, and then verify the correlation between nutrient metabolism related gene SNP and nutrient nutrition status .The second part selects iron and selenium which are commonly lacking in Chinese women of childbearing age. A intervention study is designed for these two nutrients. According to the SNP grouping of related gene loci, observe the effect of nutrition intervention and explore the nutrition intervention strategies of different SNP individuals.

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

性别
Female
接受健康志愿者

入选标准

  • preparing for pregnancy or early pregnancy women (< 12w)
  • no major surgery, trauma, or important viscera disease
  • no long-term medication history
  • No serious mental and psychological behavior abnormalities
  • resident in Beijing, can accept regular prenatal in Beijing area
  • signed informed consent

排除标准

  • have taken medications that may affect the metabolism of nutrients, but are unable to provide their ingredients or doses, making it difficult to judge their effects
  • From the first three months of this pregnancy to the time of inclusion, taking drugs that interfere with the absorption, metabolism, and utilization of nutrients.
  • From the first three months of this pregnancy to the time of inclusion, Pregnant woman took iron, selenium, vitamin B6, vitamin B12, vitamin D preparations, and the dosage was higher than the corresponding physiological standard.

研究组 & 干预措施

Normal selenium

Experimental

干预措施: Normal selenium (Dietary Supplement)

Normal selenium

Experimental

干预措施: Weak selenium (Dietary Supplement)

Weak selenium

Experimental

干预措施: Normal selenium (Dietary Supplement)

Weak selenium

Experimental

干预措施: Weak selenium (Dietary Supplement)

Normal iron

Experimental

干预措施: Normal iron (Dietary Supplement)

Normal iron

Experimental

干预措施: Weak iron (Dietary Supplement)

Weak iron

Experimental

干预措施: Normal iron (Dietary Supplement)

Weak iron

Experimental

干预措施: Weak iron (Dietary Supplement)

结局指标

主要结局

Correlation between gestational diabetes-related gene monitoring results and glycosylated hemoglobin,fasting blood glucose, fasting insulin levels in vivo

时间窗: lasted for 4 weeks

The correlation between the nutrition evaluation results of gestational diabetes-related gene monitoring and the levels of glycosylated hemoglobin,fasting blood glucose, fasting insulin in vivo

Correlation between the results of nutritional evaluation of selenium-related genes and selenium levels in vivo

时间窗: lasted for 4 weeks

The correlation between the nutrition evaluation results of selenium gene monitoring and the levels of selenium in vivo

Correlation between the results of nutritional evaluation of iron-related genes and iron levels in vivo

时间窗: lasted for 4 weeks

The correlation between the nutrition evaluation results of iron gene monitoring and the levels of iron in vivo

Correlation between the results of nutritional evaluation of vitamin B6-related genes and vitamin B6 levels in vivo

时间窗: lasted for 4 weeks

The correlation between the nutrition evaluation results of vitamin B6 gene monitoring and the levels of vitamin B6 in vivo

Correlation between the results of nutritional evaluation of vitamin B12-related genes and vitamin B12 levels in vivo

时间窗: lasted for 4 weeks

The correlation between the nutrition evaluation results of vitamin B12 gene monitoring and the levels of vitamin B12 in vivo

Correlation between the results of nutritional evaluation of vitamin D-related genes and vitamin D levels in vivo

时间窗: lasted for 4 weeks

The correlation between the nutrition evaluation results of vitamin D gene monitoring and the levels of vitamin D in vivo

Correlation between the results of nutritional evaluation of pantothenic acid-related genes and pantothenic acid levels in vivo

时间窗: lasted for 4 weeks

The correlation between the nutrition evaluation results of pantothenic acid gene monitoring and the levels of pantothenic acid in vivo

Correlation between gestational hypertension-related gene monitoring results and homocysteine, serum folic acid and RBC Folate levels in vivo

时间窗: lasted for 4 weeks

TThe correlation between the nutrition evaluation results of gestational hypertension-related gene monitoring and the levels of homocysteine, serum folic acid and RBC Folate in vivo

Correlation between hyperlipidemia-related gene monitoring results and the level of plasma lipid in vivo.

时间窗: lasted for 4 weeks

The correlation between the nutrition evaluation results of hyperlipidemia-related gene monitoring and the levels of plasma lipid in vivo

nutritional status

时间窗: lasted for 4 weeks

The nutritional status of selenium was compared between the normal selenium and week selenium group; The nutritional status of iron was compared between the normal iron and the weak group. Meanwhile, compare the selenium and iron nutritional status of the four groups before and after the intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liuyanping

Clinical Professor

Peking Union Medical College Hospital

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