Actively Recruiting
Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
Led by University of Ulm · Updated on 2026-04-07
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore how parental metabolism during pregnancy affects fetal epigenetic patterns, focusing on gestational diabetes. It investigates how inherited epigenetic changes influence gene activity and disease risk in children. The study addresses the challenge of studying these effects in humans due to ethical concerns and the risks of invasive fetal sampling. Pregnant women between 20 and 28 weeks of gestation and their partners will be recruited. Mothers will undergo an oral glucose tolerance test to evaluate metabolism and detect gestational diabetes. Blood samples will be taken from both parents to analyze their metabolic profiles and epigenetic signatures. Fetal epigenetic patterns will be examined through analysis of fetal cell-free DNA circulating in the mother's blood. Participants will provide blood samples and metabolic data during pregnancy. Researchers will analyze epigenetic profiles and their correlation with glucose metabolism, insulin sensitivity, and lipid levels. The primary outcome is the epigenetic profiles of parents and fetuses at baseline. The study will monitor safety and collect data until July 2028, with voluntary consent required for participation.
CONDITIONS
Brief Title
Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women between 20 and 28 weeks of gestation
- The father of the child is known and willing to participate in the study
- No known underlying medical conditions in either parent
- No fetal abnormalities detected in first-trimester screening, detailed fetal anatomy ultrasound, non-invasive prenatal testing (NIPT), or any additional prenatal examinations performed, if applicable
- Understanding and voluntary signing of a consent form before study-related examinations
You will not qualify if you...
- Age less than 18 years
- Type 1 or type 2 diabetes mellitus
- Pharmacological treatment affecting blood glucose levels (e.g., steroids, insulin)
- Endocrine disorders (e.g., hyperthyroidism, polycystic ovary syndrome [PCOS])
- Current depression or other psychiatric disorders
- Eating disorders
- Regular use of medication during pregnancy
- Pre-existing cardiovascular disease
- Drug and/or alcohol abuse
- Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m²
- C-reactive protein greater than 10 mg/l
- Transaminase elevation of 2 times the upper norm
- No consent to be informed about incidentally discovered pathological findings
- Any other (clinical) condition that would endanger participants safety or question scientific success according to the physician's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment between gestational weeks 24 and 28
Participants undergo metabolic and epigenetic characterization including oral glucose tolerance tests and blood sampling for methylation analyses.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Ulm University Hospital
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
Research Team
M
Martin Heni, Prof, MD
S
Sabrina Wangler
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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