Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy (MuKiLOG)

Jena University Hospital

Status: Active, not recruiting

Conditions: Diabetes, Gestational; Pregnancy Diabetic

Treatments: Behavioral: Psychometric examination; Other: Physical examination; Diagnostic Test: Recording of the adrenergic stress reaction (saliva test); Other: Basic data collection (online survey or written form)

Study type: Observational

Funder types: Other

Identifiers

NCT04417452

2019-1403

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Mothers / children after diabetes in pregnancy

Description:

The study collective is composed of mother-child pairs after gestational diabetes, which were supervised in the Competence Center for Diabetes and Pregnancy at the University Hospital of Jena. The patients can decide to fill in an online questionnaire. For all other parts of the study, only patients who have been informed individually or on behalf of their legal guardian about the nature of the study after a detailed and understandable explanatory discussion with an investigator and who have given written consent will be included in the study.

Treatment:

Diagnostic Test: Recording of the adrenergic stress reaction (saliva test)

Other: Physical examination

Other: Basic data collection (online survey or written form)

Behavioral: Psychometric examination

Controls

Description:

The control collective is composed of mother-child pairs who were cared for at the same time as the study collective at the University Hospital Jena. This collective is status post singleton pregnancy and term birth. The patients can decide to fill in an online questionnaire. For all other parts of the study, only patients who have been informed individually or on behalf of their legal guardian about the nature of the study after a detailed and understandable explanatory discussion with an investigator and who have given written consent will be included in the study.

Treatment:

Diagnostic Test: Recording of the adrenergic stress reaction (saliva test)

Other: Physical examination

Other: Basic data collection (online survey or written form)

Behavioral: Psychometric examination