Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
University of Ulm
80 participants
Mar 1, 2026
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria14
- 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.
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07436195