Effects of Fetal Programming on the Metabolic, Cardiovascular, Neurocognitive and Reproductive Health of Offsprings and Their Mothers After Pregnancies With Diabetes
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes, Gestational
- Sponsor
- Jena University Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Neurocognitive development
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objectives of the proposed project are to assess the long-term effects of prenatal exposure to gestational diabetes or diabetes on the maturation and health of the offspring. In addition, the long-term changes on the health of the affected mothers will be investigated, taking into account the metabolic adjustment during index pregnancy. The expected results will help to establish possible prevention strategies to fight the epidemic of non-communicable diseases for the offspring and the mothers.
Detailed Description
Investigation of the long-term outcome of mother-child pairs after diabetic pregnancies and a comparison group regarding metabolic, cardiovascular, neurocognitive and reproductive long-term changes as a function of the course of pregnancy and metabolic control
Investigators
Eligibility Criteria
Inclusion Criteria
- •For the pilot project: Initial participation in the preliminary study
- •Written Informed Consent
- •Singleton pregnancies
- •Delivery at the University Hospital Jena
- •Exclusion criteria:
- •Severe physical and mental illness
- •Patients who refuse to participate in the study or drop out
- •Premature birth, i.e. birth of the child \<37/0 weeks of gestation
- •Serious pregnancy complications
- •Prenatally known serious malformations
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Neurocognitive development
Time Frame: 1 day examination at the study centre
effects on neurocognitive development, mental health and adrenal and autonomic stress reactivity (mothers and children)
Metabolic health
Time Frame: 1 day examination at the study centre
effects on metabolic health such as glucose tolerance disorders and diabetes mellitus, obesity and metabolic syndrome (mothers and children)
Cardiovascular and vascular health
Time Frame: 1 day examination at the study centre
effects on cardiovascular and vascular health of blood pressure regulation and endothelial function (mothers and children)
Maturation of the gonadal regulation
Time Frame: 1 day examination at the study centre
maturation of gonadal regulation, pubertal development and reproductive health (children)