Actively Recruiting
Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
Led by University of Ulm · Updated on 2026-04-07
80
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Age less than 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) less than 60 ml/min/1.73 m8
- C-reactive protein greater than 10 mg/l
- Transaminase elevation of 2 times the upper normal limit
- No consent to be informed about incidentally discovered pathological findings
- Any other (clinical) condition that would endanger participant safety or question scientific success according to the physician's opinion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ulm University Hospital
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
Research Team
M
Martin Heni, Prof, MD
CONTACT
S
Sabrina Wangler
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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