An observational study in Gestational Diabetes Mellitus (GDM), sponsored by University of Ulm. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by University of Ulm · Observational
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.
Epigenetic patterns inherited from both parents significantly influence gene expression and disease susceptibility in their offspring, with particularly negative effects in gestational diabetes, as indicated in animal and observational studies. However, human studies are limited due to the complexity and ethical concerns of collecting samples from fetuses and newborns. Invasive fetal sampling methods carry a risk of pregnancy loss, but the discovery of fetal cell-free DNA in maternal blood has revolutionized prenatal diagnostics by providing a non-invasive alternative. Recent advancements have made it possible to use cell-free DNA analyses also for epigenetic characterizations. The primary objective of this project is to elucidate the bidirectional epigenetic interactions between maternal gestational metabolism and the fetal epigenome, with a focus on identifying and understanding the biological impacts of epigenetic modifications in both the mother and fetus. Additionally, the research seeks to uncover epigenetic biomarkers that are linked to gestational diabetes and to assess the influence of parental epigenetic marks on the fetus. It will examine how parental epigenetics and parental glucose metabolism affects these modifications, facilitating a detailed analysis of the origins and mechanisms of epigenetic transmission.
We will recruit couples between gestational weeks 24 and 28, with and without gestational diabetes, and perform metabolic characterizations. Maternal cell-free DNA (including fetal DNA), maternal nuclear DNA, and paternal nuclear and cell-free DNA will be collected for methylation analyses.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 80 is below the median of 180 across 289 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Ulm is the lead sponsor of 143 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from the outpatient clinic of the department of obstetrics and gynaecology at Ulm University Hospital as well as from as well as through public advertisements posted at Ulm University.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metabolic and epigenetic characterization
Other: 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
Epigenetic profiles of parents and fetuses
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.
Time frame: Baseline
Epigenetic signatures of gestational diabetes
Differentially methylated regions will be computed across parental genomic DNA and fetal cell-free DNA between women with and without gestational diabetes. Differentially methylated regions will be bioinformatically annotated to candidate genes and pathogenic pathways.
Time frame: Baseline
Correlation of epigenetic signatures and glycemia
Glucose level assessed from glucose measurements from fasting blood sample or oral glucose tolerance test.
Time frame: Baseline
Correlation of epigenetic signatures and insulin sensitivity
Insulin sensitivity assessed by Homeostasis Model Assessment of insulin resistance based on glucose and insulin measurements from fasting blood sample or oral glucose tolerance test.
Time frame: Baseline
Correlation of epigenetic signatures and insulin secretion
Insulin secretion assessed by Homeostasis Model Assessment of beta-cell function based on glucose and insulin measurements from fasting blood sample and oral glucose tolerance test.
Time frame: Baseline
Correlation of epigenetic signatures and lipids
Lipid profiles assessed from lipid measurements from fasting blood sample.
Time frame: Baseline
Plan to share: No
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