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Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA

RECRUITINGSponsored by University of Ulm
Actively Recruiting
SponsorUniversity of Ulm
Started2026-03-01
Est. completion2028-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

This clinical trials aims to investigate the impact of parental metabolism during pregnancy on fetal epigenetic signatures. The metabolic profiles of both parents will be evaluated through a blood sample collected from the father and an oral glucose tolerance test administered to the pregnant mother. Additionally, epigenetic signatures will be assessed using parental blood samples. Fetal epigenetic signatures can be identified by analyzing fetal cell-free DNA that circulates in the mother's bloodstream.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

DiabetesGestational Diabetes Mellitus (GDM)

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