Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy

Active, not recruiting

• Conditions: Pregnancy Diabetic; Diabetes, Gestational

• Registration Number: NCT04417452
• Lead Sponsor: Jena University Hospital

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

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-04
• Primary Completion: 2022-10-25
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurocognitive development	1 day examination at the study centre	effects on neurocognitive development, mental health and adrenal and autonomic stress reactivity (mothers and children)
Metabolic health	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	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	1 day examination at the study centre	maturation of gonadal regulation, pubertal development and reproductive health (children)

Trial Locations

Locations (1)

Universitätsklinikum Jena; 🇩🇪 Jena, Thüringen, Germany