Gestational Diabetes Mellitus (GDM)GRAZ-GDMNCT07459907
Gestational Diabetes and Health Outcomes in Mothers and Babies
An observational study of Gestational Diabetes Mellitus (GDM) and Pregnancy, run by Medical University of Graz at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Pregnancy
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- 15 Jun 2025to Jun 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ongoing pregnancy prior to the 32nd gestational week and a positive GDM screening
Who cannot join
- gestational age 32nd gestational week
- fetal genetic anomalies /malformation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Medical University of Graz
Graz, 8036
Evelyn Jantscher-Krenn, PhD, +43 316 385 80076, evelyn.jantscher-krenn@medunigraz.at
Christina Stern, Dr. med., christina.stern@medunigraz.at
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus (GDM), Pregnancy
- Keywords
- GDM, Insulin resistance, Glucose metabolism, Cardiometabolic risk, Pregnancy outcomes, Pregnancy phenotyping, Maternal and infant health, Pregnancy, Post-partum follow up, Longitudinal cohort, Fetal growth, Neonatal adiposity
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal metabolic and cardiometabolic phenotype: Adiposity
Measured as fat mass and fat-free mass by air displacement plethysmography longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
Measured: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Maternal metabolic and cardiometabolic phenotype: fasting glucose
Fasting blood glucose as measured in mg/mL from NaF blood tubes longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
Measured: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Maternal metabolic and cardiometabolic phenotype: blood pressure
Resting systolic and diastolic blood pressure measured using standardized clinical procedures after gestational diabetes diagnosis and during early postpartum follow-up.
Measured: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Maternal metabolic and cardiometabolic phenotype: cytokine profile
Serum cytokine will be analysed by multiplexing after gestational diabetes diagnosis and during early postpartum follow-up.
Measured: 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)
Lipid profiles are measured after gestational diabetes diagnosis and during early postpartum follow-up.
Measured: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Maternal metabolic and cardiometabolic phenotype: endothelial function
Endothelial function measured as pulse wave velocity using a Vicorder® after gestational diabetes diagnosis and during early postpartum follow-up.
Measured: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.
Infant outcomes: adiposity
Measured as fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)
Measured: At birth and at 8-12 weeks postpartum.
Infant outcomes: Neonatal C-peptide in cord blood
Concentrations of C-peptide in cord blood serum
Measured: At birth
Infant outcomes: Neonatal glucose in cord blood
Concentrations of glucose in cord blood serum
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Jun 2025
- Primary completionJun 2030 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Stern, Dr. med., Principal investigator, Medical University of GrazUrsula Hiden, PhD, Principal investigator, Medical University of GrazEvelyn Jantscher-Krenn, PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459907
- Sponsor's protocol ID
- 1031/2025
- Acronym
- GRAZ-GDM
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Effects of Gestational Diabetes on Mother and Baby
- ClinicalTrials.gov ID
- NCT07459907
- Acronym / sponsor ID
- GRAZ-GDM / 1031/2025
- Conditions
- Gestational Diabetes Mellitus (GDM), Pregnancy
- Keywords
- GDM, Insulin resistance, Glucose metabolism, Cardiometabolic risk, Pregnancy outcomes, Pregnancy phenotyping, Maternal and infant health, Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 10 Mar 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ongoing pregnancy prior to the 32nd gestational week and a positive GDM screening
Key exclusion criteria (2 listed)
- gestational age 32nd gestational week
- fetal genetic anomalies /malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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)
Infant outcomes: Neonatal C-peptide in cord blood
Time frame: At birth
Concentrations of C-peptide in cord blood serum
Infant outcomes: Neonatal glucose in cord blood
Time frame: At birth
Concentrations of glucose in cord blood serum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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.
Christina Stern, Dr. med. principal investigator
Medical University of Graz
Ursula Hiden, PhD principal investigator
Medical University of Graz
Evelyn Jantscher-Krenn, PhD principal investigator
Medical University of Graz
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 Mellitus (GDM) and Pregnancy, run by Medical University of Graz at 1 site in Austria.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evelyn Jantscher-Krenn, PhD (+43 316 385 80076, evelyn.jantscher-krenn@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal metabolic and cardiometabolic phenotype: Adiposity (time frame: From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.). The study lists 9 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 13 Apr 2026.