NCT07436195 Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
| NCT ID | NCT07436195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ulm |
| Condition | Gestational Diabetes Mellitus (GDM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2026-03-30 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07436195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gestational Diabetes Mellitus (GDM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07436195 currently recruiting?
Yes, NCT07436195 is actively recruiting participants. Contact the research team at martin.heni@uniklinik-ulm.de for enrollment information.
Where is the NCT07436195 trial being conducted?
This trial is being conducted at Ulm, Germany.
Who is sponsoring the NCT07436195 clinical trial?
NCT07436195 is sponsored by University of Ulm. The trial plans to enroll 80 participants.
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