The Association of Reduced Arterial Stiffness and Highly Sensitive C-reactive Protein With Gestational Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The arterial stiffness in pregnant women with gestational diabetes is reduced compared to healthy pregnant women.
研究概览
简要总结
Research hypotheses
- The arterial stiffness in pregnant women with gestational diabetes is reduced compared to healthy pregnant women.
- The values of highly sensitive CRP in pregnant women with gestational diabetes are higher compared to healthy pregnant women.
- The arterial stiffness in test subjects with previous gestational diabetes was reduced compared to test subjects with a previously normal OGTT during pregnancy.
- The values of highly sensitive CRP in subjects with previous gestational diabetes are higher compared to subjects with previously normal OGTT during pregnancy.
详细描述
Gestational diabetes is a growing problem at the global level, and it brings with it numerous perinatal and maternal complications. In addition, it is associated with a higher risk of developing type 2 diabetes and cardiovascular disease later in life. However, the mechanisms by which this happens have not been fully elucidated, which is why the possibilities of prevention are limited. Insulin resistance is recognized as a cause of GDM and associated with a decrease in arterial elasticity due to its pro-inflammatory pathogenesis, which is manifested by an increase in pro-inflammatory biomarkers, such as hs CRP. However, the application of these findings has not yet taken root in practice.
It is necessary to find reliable methods of screening pregnant women with GDM who have an increased risk of developing complications both during pregnancy and later in life.
Reduced arterial elasticity is recognized as a predictor of cardiovascular diseases, and its measurement is recommended to be introduced into clinical practice. On the other hand, measuring hsCRP is simple and available, but its practical application is still questionable and additional research is needed. Several studies have attempted to link GDM with reduced arterial elasticity and/or increased hs CRP, but the conclusions are contradictory, probably due to the small number of subjects. On the other hand, I did not find studies that measured the mentioned parameters just after delivery for the purpose of predicting cardiovascular risk (80-82 ref from MR).
This research will try to prove the association of GDM with reduced arterial stiffness and elevated hsCRP values. The results will attempt to justify the introduction into clinical practice of measuring arterial elasticity and hsCRP in order to find pregnant women at risk of developing complications during and after pregnancy.
Research objectives
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
- 是
入选标准
- •age between 18 and 35 years
- •previously healthy women
- •previously normal course of pregnancy
- •singleton pregnancies
- •non-smokers
排除标准
- •pregestational diabetes
- •gestational diabetes and/or hypertensive disorders in pregnancy in previous pregnancies
- •hypertensive disorders during pregnancy at the time of examination
- •chronic diseases
- •pregnant women whose partner previously had a partner with preeclampsia
结局指标
主要结局
The arterial stiffness in pregnant women with gestational diabetes is reduced compared to healthy pregnant women.
时间窗: between 28 and 40 weeks of gestation
The non-invasive oscillometric device Arteriograph will be used to measure the arterial stiffness.The examiners will use a gynecological divider to measure the distance between the jugulum and the symphysis, which represents the approximate length of the aorta, and the obtained value will be entered into the device
The values of highly sensitive CRP in pregnant women with gestational diabetes are higher compared to healthy pregnant women.
时间窗: between 28 and 40 weeks of gestation
The test subjects will have a venous blood sample taken to determine the value of highly sensitive C-reactive C protein from the serum.
次要结局
未报告次要终点
研究者
Ana Dugandžić Šimić
mr. sc. Ana Dugandžić Šimić, ob/gyn specialist
University of Mostar
