Parental metabolism's imprint on the fetal epigenome in gestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Protective effect of lactation on gestational diabetes in a future pregnancy

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• Natural cervical ripening to delay pharmacological induction of labor

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.