University of Mostar
Mostar, 88000, Bosnia and Herzegovina
NCT Number: NCT05479565
Research hypotheses
1. The arterial stiffness in pregnant women with gestational diabetes is reduced compared to healthy pregnant women. 2. The values of highly sensitive CRP in pregnant women with gestational diabetes are higher compared to healthy pregnant women. 3. The arterial stiffness in test subjects with previous gestational diabetes was reduced compared to test subjects with a previously normal OGTT during pregnancy. 4. The values of highly sensitive CRP in subjects with previous gestational diabetes are higher compared to subjects with previously normal OGTT during pregnancy.
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Notify Me18 year–35 year
Female
Observational
Mostar, 88000, Bosnia and Herzegovina
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
Main goals:
Secondary objectives:
The purpose of the research
Measurement of arterial stiffness and high-sensitivity CRP values could, based on the results of this study, be introduced into clinical practice as predictors of GDM-related complications in pregnancy and later in life.
Research hypotheses
Respondents:
The diagnosis of gestational diabetes will be made on the basis of the pathological findings of the OGTT, according to WHO criteria from 2013: the OGTT will be performed with 75 g of glucose, and it is sufficient that only one of the stated concentrations of glucose taken from the mother's venous blood plasma is equal to or higher from borderline:
At the same time, the glycemic values must not meet the criteria for manifest diabetes:
Criteria for the inclusion of test subjects:
Exclusion criteria
The test subjects will have a venous blood sample taken to determine the value of highly sensitive C-reactive C protein from the serum and measure the arterial stiffness.
The non-invasive oscillometric device Arteriograph (TensioMedTM Kft, Budapest, Hungary) will be used to measure the arterial stiffness.
The indicators of arterial stiffnesses, which will be used in the analysis, will be:
Pregnant women will then be monitored until delivery, in order to determine whether they will develop the following pregnancy complications:
Also, it will be determined what the perinatal outcome of the newborn will be, i.e. whether there will be:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The non-invasive oscillometric device Arteriograph (TensioMedTM Kft, Budapest, Hungary) will be used to measure the arterial stiffness. In a quiet room at room temperature, the subjects will lie relaxed for 15 minutes before the start of the measurement. After that, the distance between the jugulum and the symphysis, which represents the approximate length of the aorta, will be measured with a gynecological compass, and the resulting value will be entered into the device.
Other names: measuring the arterial stiffness
Time frame: 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
Time frame: 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.
University of Mostar
Other
The Association of Reduced Arterial Stiffness and Highly Sensitive C-reactive Protein With Gestational Diabetes Mellitus.
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