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

NCT05479565 | Completed DMC

• 1 other identifier: Arterial stiffness, GDM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Research hypotheses

1. 1.The arterial stiffness in pregnant women with gestational diabetes is reduced compared to healthy pregnant women.
2. 2.The values of highly sensitive CRP in pregnant women with gestational diabetes are higher compared to healthy pregnant women.
3. 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. 4.The values of highly sensitive CRP in subjects with previous gestational diabetes are higher compared to subjects with previously normal OGTT during pregnancy.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  between 28 and 40 weeks of gestation

Study Arms (2)

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.

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

Diagnostic Test: venous blood sample for determining the value of highly sensitive C-reactive C protein from serum

Interventions

venous blood sample for determining the value of highly sensitive C-reactive C protein from serum DIAGNOSTIC_TEST

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.

Also known as: measuring the arterial stiffness

50 pregnant women with patological OGTT; 50 pregnant women with regular OGTT

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mostar: lead

Study Sites (1)

University of Mostar

Mostar, 88000, Bosnia and Herzegovina

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood.

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Vajdana Tomić, prof.dr.sc.

  Faculty of Health Studies, Mostar

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mr. sc. Ana Dugandžić Šimić, ob/gyn specialist

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 29, 2022
• Study Start: September 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 Years folowing article publication.
• Access Criteria: Investigators whose proposed use the Data has been approved by an Independent review committee identified for this purpose.

Locations

BO (1)