Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:13 AM
Study NCT ID:
NCT07436195
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053858', 'term': 'Metabolic Networks and Pathways'}], 'ancestors': [{'id': 'D008660', 'term': 'Metabolism'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'For DNA and cell-free -DNA isolation, EDTA-Plasma and special tubes that stabilize cell-free DNA will be obtained. Moreover, serum and lithium heparin samples will be obtained to determine parameters such as insulin and c-peptide.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epigenetic profiles of parents and fetuses', 'timeFrame': 'Baseline', 'description': 'Methylation pattern of CpG sites in fathers, mothers and fetuses assessed from blood samples from the father and the mother.\n\nGenome-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.\n\nFetal 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.'}], 'secondaryOutcomes': [{'measure': 'Epigenetic signatures of gestational diabetes', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Correlation of epigenetic signatures and glycemia', 'timeFrame': 'Baseline', 'description': 'Glucose level assessed from glucose measurements from fasting blood sample or oral glucose tolerance test.'}, {'measure': 'Correlation of epigenetic signatures and insulin sensitivity', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Correlation of epigenetic signatures and insulin secretion', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Correlation of epigenetic signatures and lipids', 'timeFrame': 'Baseline', 'description': 'Lipid profiles assessed from lipid measurements from fasting blood sample.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epigenetics', 'pregnancy', 'parental metabolism', 'Cell-free DNA', 'gestational diabetes'], 'conditions': ['Gestational Diabetes Mellitus (GDM)']}, 'descriptionModule': {'briefSummary': "This clinical trials aims to investigate the impact of parental metabolism during pregnancy on fetal epigenetic signatures.\n\nThe 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.", 'detailedDescription': '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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 20 and 28 weeks of gestation\n* The father of the child is known and willing to participate in the study\n* No known underlying medical conditions in either parent\n* 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\n* No known underlying diseases\n* Understanding and voluntary signing of a consent form before study- related examinations\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Type 1 or type 2 diabetes mellitus\n* Pharmacological treatment affecting blood glucose levels (e.g., steroids, insulin)\n* Endocrine disorders (e.g., hyperthyroidism, polycystic ovary syndrome \\[PCOS\\])\n* Current depression or other psychiatric disorders\n* Eating disorders\n* Regular use of medication during pregnancy\n* Pre-existing cardiovascular disease\n* Drug and/or alcohol abuse\n* Estimated glomerular filtration rate (eGFR) \\< 60 ml/min/1.73 m²\n* C-reactive protein \\> 10 mg/l\n* Transaminase elevation of 2 times the upper norm\n* No consent to be informed about incidentally discovered pathological findings\n* Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.'}, 'identificationModule': {'nctId': 'NCT07436195', 'acronym': 'Epi_GDM', 'briefTitle': 'Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA', 'orgStudyIdInfo': {'id': '28/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women + fathers of the unborn child', 'description': 'Metabolic and epigenetic characterization', 'interventionNames': ['Other: Metabolic and epigenetic characterization of parents ans fetuses']}], 'interventions': [{'name': 'Metabolic and epigenetic characterization of parents ans fetuses', 'type': 'OTHER', 'description': "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.\n\nFathers will undergo (if possible fasting) blood sample to characterize metabolism and epigenetic signatures", 'armGroupLabels': ['Pregnant women + fathers of the unborn child']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Heni, Prof.', 'role': 'CONTACT', 'email': 'martin.heni@uniklinik-ulm.de', 'phone': '+49 731 500 44505'}, {'name': 'Sabrina Wangler', 'role': 'CONTACT', 'email': 'sabrina.wangler@uniklinik-ulm.de', 'phone': '+49 731 500 44782'}], 'facility': 'Ulm University Hospital', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'centralContacts': [{'name': 'Martin Heni, Prof, MD', 'role': 'CONTACT', 'email': 'martin.heni@uniklinik-ulm.de', 'phone': '+49 731 500 44505'}, {'name': 'Sabrina Wangler', 'role': 'CONTACT', 'email': 'sabrina.wangler@uniklinik-ulm.de', 'phone': '+49 731 500 44782'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med Martin Heni', 'investigatorFullName': 'Martin Heni', 'investigatorAffiliation': 'University of Ulm'}}}}