Parental metabolism's imprint on the fetal epigenome in gestational diabetes
Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
We will see if parents' metabolism during pregnancy is linked to epigenetic changes in the fetus in pregnancies with and without gestational diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ulm Academic / other |
| Locations | 1 site (Ulm, Baden-Wurttemberg) |
| Trial ID | NCT07436195 on ClinicalTrials.gov |
What this trial studies
This observational project enrolls pregnant people (20–28 weeks gestation) and their partners, including pregnancies with and without gestational diabetes. Maternal and paternal blood samples will be collected, the mother will undergo an oral glucose tolerance test, and fetal cell-free DNA will be isolated from maternal plasma for epigenetic profiling. Metabolic profiles of both parents will be compared with parental and fetal epigenetic signatures to identify associated modifications. The study aims to map bidirectional epigenetic interactions and to identify biomarkers linked to gestational diabetes-related fetal epigenetic changes.
Who should consider this trial
Good fit: Ideal candidates are pregnant people between 20 and 28 weeks gestation and their known partners, without major medical or psychiatric conditions, who can provide blood samples and give informed consent.
Not a fit: People with pre-existing type 1 or type 2 diabetes, those taking medications that affect blood glucose, pregnancies with detected fetal abnormalities, or individuals with significant medical or psychiatric disorders are unlikely to benefit from this observational profiling.
Why it matters
Potential benefit: If successful, the work could identify non-invasive epigenetic biomarkers that help predict which pregnancies show gestational diabetes–related fetal changes and inform earlier monitoring or prevention.
How similar studies have performed: Animal experiments and limited human observational work suggest parental metabolism can affect offspring epigenetics, and recent non-invasive cell-free DNA methods enable this novel human-focused approach though direct human evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * No known underlying diseases * Understanding and voluntary signing of a consent form before study- related examinations Exclusion Criteria: * Age \< 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) \< 60 ml/min/1.73 m² * C-reactive protein \> 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 physicians opinion.
Where this trial is running
Ulm, Baden-Wurttemberg
- Ulm University Hospital — Ulm, Baden-Wurttemberg, Germany (Recruiting)
Study contacts
- Study coordinator: Martin Heni, Prof, MD
- Email: martin.heni@uniklinik-ulm.de
- Phone: +49 731 500 44505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.