Metabolic and epigenetic characterization of parents ans fetuses
Metabolic and epigenetic characterization of parents ans fetuses: Pregnant women will undergo an oral glucose tolerance test to characterize metabolism and assess the presence of gestational diabetes. Moreover, they will undergo blood sampling to assess the mothers' epigenetic signatures and the fetal epigenetic signatures based on circulating fetal cell-free DNA.
Fathers will undergo (if possible fasting) blood sample to characterize metabolism and epigenetic signatures
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
Epigenetic profiles of parents and fetuses — Baseline Methylation pattern of CpG sites in fathers, mothers and fetuses assessed from blood samples from the father and the mother.
Genome-wide DNA methylation will be quantified as 5-methylcytosine (5mC) levels at CpG sites in maternal and paternal nuclear DNA from peripheral blood. Long-read sequencing will be used to detect genomic sequences and base modifications.
Fetal DNA methylation will be assessed from fetal cell-free DNA isolated from maternal plasma using long-read sequencing. Allelic phasing will be applied to assign epigenetic modifications to parental origin. Deconvolution analysis will be used to subtract blood cell-derived epigenetic patterns and infer tissue-of-origin signals.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.