Gestational Diabetes and Health Outcomes in Mothers and Babies (GRAZ-GDM)

April 9, 2026 updated by: Medical University of Graz

Understanding the Effects of Gestational Diabetes on Mother and Baby

Gestational diabetes mellitus (GDM) is a common pregnancy complication characterized by impaired glucose metabolism and increased insulin resistance. GDM is associated with adverse pregnancy outcomes and an increased long-term risk of metabolic and cardiovascular disease for both mother and offspring.

This prospective observational cohort study aims to establish a longitudinal pregnancy and birth cohort of women diagnosed with GDM. Pregnant women with a positive 75 g oral glucose tolerance test (OGTT) between gestational weeks 24 and 28 will be recruited after diagnosis and followed through late pregnancy, delivery, and early postpartum.

Participants will undergo two study visits during pregnancy, sample collection at delivery, and one postpartum visit 8-12 weeks after birth. Clinical data, physical measurements, questionnaire-based information, and biological samples will be collected from mothers and infants to enable comprehensive phenotyping of GDM pregnancies.

Data and biosamples from this cohort will be used for descriptive and hypothesis-driven analyses and may be compared with data from an existing longitudinal cohort of healthy pregnancies to support interpretation of GDM-related changes.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Gestational diabetes mellitus (GDM) develops when physiological insulin resistance during pregnancy exceeds adaptive capacity, resulting in impaired glucose regulation. GDM is associated with increased perinatal morbidity and elevated long-term risk for metabolic and cardiovascular disease in both mothers and offspring. Despite its clinical relevance, the biological mechanisms underlying GDM and its long-term consequences are incompletely understood.

This prospective, monocentric observational cohort study is designed to establish a well-characterized longitudinal pregnancy and birth cohort of women diagnosed with GDM. The primary objective is to collect clinical data and biological samples across pregnancy, delivery, and early postpartum to support detailed phenotyping of GDM pregnancies and early-life outcomes.

Approximately 100 pregnant women with a confirmed diagnosis of GDM will be recruited per year at the Department of Obstetrics and Gynecology. Eligible participants are women aged 18 years or older with an ongoing pregnancy prior to gestational week 32 and a positive 75 g OGTT performed as part of routine clinical care. Women with major fetal anomalies are excluded.

Study participation includes four time points: 1.) a visit following GDM diagnosis (approximately gestational weeks 26-30), 2.) a late pregnancy visit (approximately weeks 34-37), 3.) sample and clinical data collection at delivery, and 4) a postpartum follow-up visit 8-12 weeks after birth.

At each study visit, standardized clinical assessments, physical measurements, and questionnaire-based information will be collected. Maternal assessments include anthropometry, body composition, blood pressure, and selected non-invasive cardiovascular and metabolic measurements. Fetal growth is assessed by routine obstetric ultrasound. At delivery, perinatal samples such as placenta, umbilical cord, and cord blood are collected. Postnatal assessments include maternal and infant anthropometry and selected cardiovascular measurements where applicable.

Biological samples collected longitudinally may include blood, urine, saliva, vaginal swabs, breast milk, placental tissue, umbilical cord tissue, and umbilical cord blood. Samples are processed and stored in a biobank for future analyses following separate ethical approvals. Clinical metadata include pregnancy outcomes, GDM treatment, delivery characteristics, and neonatal outcomes.

Lifestyle and behavioral factors, including nutrition and physical activity, are assessed using standardized questionnaires. Data are pseudonymized and handled in accordance with applicable data protection regulations.

This study is designed as a cohort and sample collection platform.

For contextual comparison, data and biosamples from an existing longitudinal cohort of healthy pregnancies will be used where appropriate. Alignment of visit timing and data collection procedures allows comparative analyses between GDM and normoglycemic pregnancies.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Department of Obstetrics and Gynecology, Medical University of Graz
        • Principal Investigator:
          • Evelyn Jantscher-Krenn, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christina Stern, Dr. med.
        • Principal Investigator:
          • Ursula Hiden, PhD
        • Sub-Investigator:
          • Federica Piani, DM, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population consists of pregnant women diagnosed with gestational diabetes mellitus (GDM) based on a positive 75 g oral glucose tolerance test performed as part of routine clinical care between gestational weeks 24 and 28. Participants are recruited after diagnosis at a tertiary care obstetric center and followed through late pregnancy, delivery, and early postpartum.

Eligible participants are adults aged 18 years or older with an ongoing singleton pregnancy prior to gestational week 32. Women with major fetal anomalies are excluded. In addition, a non-pregnant reference cohort of healthy adult males and non-pregnant females may be recruited for selected analyses to provide pregnancy- and sex-independent reference data.

Description

Inclusion Criteria:

  • ongoing pregnancy prior to the 32nd gestational week and a positive GDM screening

Exclusion Criteria:

  • gestational age 32nd gestational week
  • fetal genetic anomalies /malformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal metabolic and cardiometabolic phenotype: Adiposity
Time Frame: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Measured as fat mass and fat-free mass by air displacement plethysmography longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Maternal metabolic and cardiometabolic phenotype: fasting glucose
Time Frame: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Fasting blood glucose as measured in mg/mL from NaF blood tubes longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Maternal metabolic and cardiometabolic phenotype: cytokine profile
Time Frame: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Serum cytokine will be analysed by multiplexing after gestational diabetes diagnosis and during early postpartum follow-up.
From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Maternal metabolic and cardiometabolic phenotype: lipid profile (triglycerides, phospholipids, free, fatty acids, HDL/LDL/total cholesterol)
Time Frame: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Lipid profiles are measured after gestational diabetes diagnosis and during early postpartum follow-up.
From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Maternal metabolic and cardiometabolic phenotype: endothelial function
Time Frame: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Endothelial function measured as pulse wave velocity using a Vicorder® after gestational diabetes diagnosis and during early postpartum follow-up.
From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Infant outcomes: adiposity
Time Frame: At birth and at 8-12 weeks postpartum.
Measured as fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)
At birth and at 8-12 weeks postpartum.
Infant outcomes: Neonatal C-peptide in cord blood
Time Frame: At birth
Concentrations of C-peptide in cord blood serum
At birth
Infant outcomes: Neonatal glucose in cord blood
Time Frame: At birth
Concentrations of glucose in cord blood serum
At birth
Maternal metabolic and cardiometabolic phenotype: blood pressure
Time Frame: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Resting systolic and diastolic blood pressure measured using standardized clinical procedures after gestational diabetes diagnosis and during early postpartum follow-up.
From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Evelyn Jantscher-Krenn, PhD, Medical University of Graz
  • Principal Investigator: Christina Stern, Dr. med., Medical University of Graz
  • Principal Investigator: Ursula Hiden, PhD, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2025

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2035

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1031/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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