Gestational Diabetes and Health Outcomes in Mothers and Babies

NCT07459907 | Recruiting

• 1 other identifier: 1031/2025
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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)

  At birth and at 8-12 weeks postpartum.

• Infant outcomes: Neonatal C-peptide in cord blood

  Concentrations of C-peptide in cord blood serum

  At birth

• Infant outcomes: Neonatal glucose in cord blood

  Concentrations of glucose in cord blood serum

  At birth

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Medical University of Graz

Graz, 8036, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Maternal samples: serum, ccfDNA (PAXgene), urine, saliva, vaginal swabs (approx. 32 wks of gestation; 35-37 wks of gestation, and 8-12 wks postpartum); Maternal/neonatal samples at delivery: maternal serum and cord blood serum; ccfDNA (PAXgene), placenta and umbilical cord tissue; amniotic fluid (C-section); colostrum (48h postpartum); human milk (8-12 weeks postpartum)

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

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; Hyperinsulinism

Study Officials

• Christina Stern, Dr. med.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Ursula Hiden, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Evelyn Jantscher-Krenn, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Jantscher-Krenn, PhD

CONTACT

+43 316 385 80076; evelyn.jantscher-krenn@medunigraz.at

Christina Stern, Dr. med.

CONTACT

+43 316 385 86306; christina.stern@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 10, 2026
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2035
• Last Updated: April 13, 2026

Record last verified: 2026-03

Locations

AU (1)