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AzTrials

Gestational DiabetesNCT05479565

Relationship of Reduced Arterial Stiffness and Hs-CRP With GDM.

An observational study of Gestational Diabetes, run by University of Mostar at 1 site in Bosnia and Herzegovina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Diabetes
What is being tested?
venous blood sample for determining the value of highly sensitive C-reactive C protein from serum
How many people
100 participants
Where
1 siteBosnia and Herzegovina
Study dates
1 Sep 2020to 1 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: * age between 18 and 35 years * previously healthy women * previously normal course of pregnancy * singleton pregnancies * non-smokers

Who may be able to join

  • age between 18 and 35 years
  • previously healthy women
  • previously normal course of pregnancy
  • singleton pregnancies
  • non-smokers

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Bosnia and Herzegovina1 site
  • University of Mostar

    Mostar, 88000

Other trials in Bosnia and Herzegovina

About this study

Official title: The Association of Reduced Arterial Stiffness and Highly Sensitive C-reactive Protein With Gestational Diabetes Mellitus.

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.
Read the detailed description

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:

  • To compare the arterial stiffness in pregnant women with gestational diabetes and healthy pregnant women.
  • To compare the values of highly sensitive CRP in pregnant women with gestational diabetes and healthy pregnant women
  • To determine whether the occurrence of cardiovascular diseases during pregnancy can be predicted by measuring the arterial stiffness and hs CRP in healthy pregnant women and pregnant women with GDM

Secondary objectives:

  • To compare the occurrence of pregnancy complications and perinatal outcome in pregnant women with gestational diabetes and healthy pregnant women.
  • To compare the srterial stiffness and the values of highly sensitive CRP in two groups of subjects 2-6 months after pregnancy.

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

  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.

Respondents:

  1. 100 pregnant women from the 28th to the 40th week of pregnancy (in the third trimester), who, as part of regular perinatal care, took the oral glucose tolerance test (OGTT), divided into two groups:
  • 50 pregnant women with pathological findings of OGTT i
  • 50 pregnant women with regular OGTT. 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:
  • fasting glycemia ≥ 5.1 mmol/l,
  • glycemia after 1h ≥ 10 mmol/l,
  • glycemia after 2h ≥ 8.5mmol/l. At the same time, the glycemic values must not meet the criteria for manifest diabetes:
  • fasting glycemia ≥ 7.0 mmol/l,
  • glycemia after 2 h ≥ 11.1 mmol/l,
  • glycemia at any time ≥ 11.1 mmol/l with the presence of diabetes symptoms. Criteria for the inclusion of test subjects:
  • age between 18 and 35 years
  • previously healthy women
  • previously normal course of pregnancy
  • singleton pregnancies
  • non-smokers Exclusion criteria:
  • 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.
  1. Two to six months after delivery of the same test subjects, divided into the same two groups: 50 test subjects with previous normal OGTT during pregnancy and 50 test subjects with previous gestational diabetes.

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:

  • pulse wave speed,
  • central systolic pressure,
  • peripheral and central values of the augmentation index,
  • peripheral and central pulse pressure values.

Pregnant women will then be monitored until delivery, in order to determine whether they will develop the following pregnancy complications:

  • hypertensive disorders (gestational hypertension, preeclampsia, eclampsia)
  • induction of labor (iatrogenic labor induction)
  • operative completion of childbirth (caesarean section or vacuum extraction)

Also, it will be determined what the perinatal outcome of the newborn will be, i.e. whether there will be:

  • macrosomia (newborn weight above 4000 g),
  • a newborn large for gestational age, a newborn weighing more than the 90th percentile for gestational age.
  • trauma during childbirth (shoulder dystocia, clavicle fracture, brachial plexus injuries),
  • metabolic disorders of the newborn (hypoglycemia, hypomagnesemia, hypocalcemia, hyperviscosity syndrome, occurrence of neonatal jaundice),
  • stay in the Neonatal Intensive Care Unit.
Being tested
venous blood sample for determining the value of highly sensitive C-reactive C protein from serum
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • venous blood sample for determining the value of highly sensitive C-reactive C protein from serumDiagnostic test

    Also called measuring the arterial stiffness

    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.

Study groups in NCT05479565
Study groupRoleWhat they receive
50 pregnant women with patological OGTT50 pregnant women with patological OGTT ( glucose load test) and after delivery - 50 women with GDM in previous pregnancy.
Receives: Diagnostic Test: venous blood sample for determining the value of highly sensitive C-reactive C protein from serum
50 pregnant women with regular OGTT50 pregnant women with regular OGTT ( glucose load test) and after delivery - 50 women without GDM in previous pregnancy
Receives: Diagnostic Test: venous blood sample for determining the value of highly sensitive C-reactive C protein from serum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The arterial stiffness in pregnant women with gestational diabetes is reduced compared to healthy pregnant women.

    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

    Measured: between 28 and 40 weeks of gestation

  2. The values of highly sensitive CRP in pregnant women with gestational diabetes are higher compared to healthy pregnant women.

    The test subjects will have a venous blood sample taken to determine the value of highly sensitive C-reactive C protein from the serum.

    Measured: between 28 and 40 weeks of gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study start1 Sep 2020
  3. Primary completion1 Sep 2023
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05479565
Sponsor's protocol ID
Arterial stiffness, GDM
Status last verified
Dec 2023
First submitted
14 Jul 2022
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Questions about this trial

What is this clinical trial studying?

An observational study of Gestational Diabetes, run by University of Mostar at 1 site in Bosnia and Herzegovina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The arterial stiffness in pregnant women with gestational diabetes is reduced compared to healthy pregnant women. (time frame: between 28 and 40 weeks of gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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