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临床试验/NCT04952324
NCT04952324已完成不适用

MTHFR Gene Mutation C6777T and Concentration of Vitamin B12, Folic Acid, Homocysteine and High Sensitive CRP in the Blood of Pregnant Women With Gestational Diabetes Mellitus.

University of Mostar2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Whether increased hs crp and homocysteine values are associated with poorer perinatal outcome

研究概览

简要总结

Research hypothesis:

  • pregnant women with gestational diabetes have elevated serum CRP values and homocysteine compared to pregnant women with normal glucose metabolism
  • Elevated CRP and homocysteine values are associated with poorer perinatal outcome.
  • reduced concentrations of folic acid and vitamin B 12 are associated with higher homocitein values
  • Carriers of the MTHFR gene mutation have higher homocysteine concentrations

详细描述

Research issues:

The basic pathophysiological mechanism of gestational diabetes is insulin resistance formed as a result of the production of placental hormones. It turned out as atherosclerosis, chronic cardiovascular diseases and diabetes share common pathophysiological mechanisms, which is nonphysiological activation of the endothelium. CRP is an acute phase protein that is synthesized in the liver to stimulate IL-6. It is a sensitive marker of inflammation and good predictor of the development of preeclampsia while the research results CRP as a predictor of gestational diabetes inconsistent. Homocysteine is a marker of endothelial dysfunction and oxidative stress. Elevated homocysteine levels are a factor risk of cardiovascular disease, and in pregnancy is associated with preeclampsia, spontaneous abortions and placental abruption.Proper adjustment of uteroplacental blood vessels is necessary for the orderly course of pregnancy these deviations from normal endothelial function will lead to pregnancy disorders.

This study is an extrapolation of recognized markers of cardiovascular risk to gestational diabetes for the purpose of predicting an adverse perinatal outcome. Examined the association of the combination of the hs-CRP marker and homocysteine with gestational diabetes and pregnancy outcome and the correlation of homocysteine and folic acid concentration acid and vitamin B12.

Research hypothesis:

  • pregnant women with gestational diabetes have elevated serum CRP values and homocysteine compared to pregnant women with normal glucose metabolism
  • Elevated CRP and homocysteine values are associated with poorer perinatal outcome.
  • reduced concentrations of folic acid and vitamin B 12 are associated with higher homocitein values
  • Carriers of the MTHFR gene mutation have higher homocysteine concentrations

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age of respondents from 18 to 35 years
  • Single pregnancies BMI from 18.5 to 29.9 kg / m 2

排除标准

  • Diagnosis of acute and chronic inflammatory diseases
  • Pregestational diabetes
  • Chronic hypertension
  • Multiple pregnancies

结局指标

主要结局

Whether increased hs crp and homocysteine values are associated with poorer perinatal outcome

时间窗: Between 24 and 28 weeks of gestation

We will meassure hs CRP and homocysteine levels in pregnant women with GDM and compare to hs CRP and homocysteine levels in pregnant women with normal glucose metabolism

carriers of the MTHFR gene mutation have higher serum homocysteine concentrations in the blood

时间窗: Between 24 and 28 weeks of gestation

We will compare serum homocysteine levels in pregnant carriers of the MTHFR gene mutation and pregnant women normal MTHFR gene mutation.

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

Ana Bošković

mr. sc. Ana Boskovic, Ob/Gyn specialist

University of Mostar

研究点 (2)

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