NCT04417452

Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy

Effects of Fetal Programming on the Metabolic, Cardiovascular, Neurocognitive and Reproductive Health of Offsprings and Their Mothers After Pregnancies With Diabetes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Jena University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes, Gestational
• Pregnancy Diabetic

Interventions

Type	Name	Description
OTHER	Basic data collection (online survey or written form)	Basic data collection is carried out by means of a questionnaire that participants can fill in outside the study centre. It contains questions about the current life situation, sleep and activity behaviour.
OTHER	Physical examination	The physical examination takes place at the study centre and includes the measurement of height, current weight and body fat, as well as the recording of heart and circulation parameters (e.g. blood pressure measurement or determination of vascular health by means of ultrasound). General metabolic and hormonal parameters are analysed by means of a blood sample. In addition, a sugar test for diabetes diagnosis will be carried out.
BEHAVIORAL	Psychometric examination	Psychometric examination is carried out at the study centre with the help of a RIAS (Reynolds Intellectual Assessment Scales and Screening) test.
DIAGNOSTIC_TEST	Recording of the adrenergic stress reaction (saliva test)	The adrenergic stress reaction is recorded by a saliva test.

Timeline

• Start date: 2019-09-01
• Primary completion: 2022-10-25
• Completion: 2023-12-31
• First posted: 2020-06-04
• Last updated: 2023-04-14

Locations

1 site across 1 country: Germany