Gestational Diabetes Mellitus (GDM)Epi_GDMNCT07436195
Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
An observational study of Gestational Diabetes Mellitus (GDM), run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Metabolic and epigenetic characterization of parents ans fetuses
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 30 Mar 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Ulm University Hospital
Ulm, Baden-Wurttemberg, 89081
Martin Heni, Prof., +49 731 500 44505, martin.heni@uniklinik-ulm.de
Sabrina Wangler, +49 731 500 44782, sabrina.wangler@uniklinik-ulm.de
About this study
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.
Read the detailed description
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.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Metabolic and epigenetic characterization of parents ans fetuses
- Keywords
- epigenetics, pregnancy, parental metabolism, Cell-free DNA, gestational diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic and epigenetic characterization of parents ans fetusesOther
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 group | Role | What they receive |
|---|---|---|
| Pregnant women + fathers of the unborn child | Metabolic and epigenetic characterization Receives: Other: Metabolic and epigenetic characterization of parents ans fetuses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
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.
Measured: Baseline
Correlation of epigenetic signatures and glycemia
Glucose level assessed from glucose measurements from fasting blood sample or oral glucose tolerance test.
Measured: 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.
Measured: 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.
Measured: Baseline
Correlation of epigenetic signatures and lipids
Lipid profiles assessed from lipid measurements from fasting blood sample.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start30 Mar 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Heni, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436195
- Sponsor's protocol ID
- 28/25
- Acronym
- Epi_GDM
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
- ClinicalTrials.gov ID
- NCT07436195
- Acronym / sponsor ID
- Epi_GDM / 28/25
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- epigenetics, pregnancy, parental metabolism, Cell-free DNA, gestational diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women + fathers of the unborn child | – | Other: Metabolic and epigenetic characterization of parents ans fetusesMetabolic and epigenetic characterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic and epigenetic characterization of parents ans fetusesPregnant 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 | Other | Pregnant women + fathers of the unborn child |
Primary outcome
Epigenetic profiles of parents and fetuses
Time frame: 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.
5 secondary outcomes
Epigenetic signatures of gestational diabetes
Time frame: Baseline
Correlation of epigenetic signatures and glycemia
Time frame: Baseline
Correlation of epigenetic signatures and insulin sensitivity
Time frame: Baseline
Correlation of epigenetic signatures and insulin secretion
Time frame: Baseline
Correlation of epigenetic signatures and lipids
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus (GDM), run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Heni, Prof, MD (+49 731 500 44505, martin.heni@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic profiles of parents and fetuses (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.