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.
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
About this study
Official title: The Association of Reduced Arterial Stiffness and Highly Sensitive C-reactive Protein With Gestational Diabetes Mellitus.
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.
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
- 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.
Respondents:
- 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.
- 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.
- Conditions
- Gestational Diabetes
- 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 group | Role | What they receive |
|---|---|---|
| 50 pregnant women with patological OGTT | 50 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 OGTT | 50 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.
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
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.
- First posted29 Jul 2022
- Study start1 Sep 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Mostar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Dugandžić Šimić, University of Mostar
- Investigators
- Vajdana Tomić, prof.dr.sc., Study chair, Faculty of Health Studies, Mostar
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Reduced Arterial Stiffness and Highly Sensitive C-reactive Protein With Gestational Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT05479565
- Acronym / sponsor ID
- Arterial stiffness, GDM
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MostarUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
Respondents:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 pregnant women with patological OGTT | – | Diagnostic Test: venous blood sample for determining the value of highly sensitive C-reactive C protein from serum50 pregnant women with patological OGTT ( glucose load test) and after delivery - 50 women with GDM in previous pregnancy. |
| 50 pregnant women with regular OGTT | – | Diagnostic Test: venous blood sample for determining the value of highly sensitive C-reactive C protein from serum50 pregnant women with regular OGTT ( glucose load test) and after delivery - 50 women without GDM in previous pregnancy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * age between 18 and 35 years * previously healthy women * previously normal course of pregnancy * singleton pregnancies * non-smokers
Key inclusion criteria (5 listed)
- age between 18 and 35 years
- previously healthy women
- previously normal course of pregnancy
- singleton pregnancies
- non-smokers
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venous blood sample for determining the value of highly sensitive C-reactive C protein from serumAlso: measuring the arterial stiffnessThe 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. | Diagnostic test | 50 pregnant women with patological OGTT, 50 pregnant women with regular OGTT |
Primary outcome
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 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vajdana Tomić, prof.dr.sc. study chair
Faculty of Health Studies, Mostar
1 site in 1 country: see every site and its status.
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.