Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy
Active, not recruiting
- Conditions
- Pregnancy DiabeticDiabetes, Gestational
- Interventions
- Other: Basic data collection (online survey or written form)Other: Physical examinationBehavioral: Psychometric examinationDiagnostic Test: Recording of the adrenergic stress reaction (saliva test)
- 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
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
- Arm && Interventions
Group Intervention Description Controls Basic data collection (online survey or written form) 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. Mothers / children after diabetes in pregnancy Basic data collection (online survey or written form) 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. Mothers / children after diabetes in pregnancy Psychometric examination 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. Controls Physical examination 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. Controls Recording of the adrenergic stress reaction (saliva test) 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. Mothers / children after diabetes in pregnancy Physical examination 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. Mothers / children after diabetes in pregnancy Recording of the adrenergic stress reaction (saliva test) 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. Controls Psychometric examination 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.
- 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitätsklinikum Jena
🇩🇪Jena, Thüringen, Germany