Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy
NCT ID: NCT04417452
Last Updated: 2023-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-09-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mothers / children after diabetes in pregnancy
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.
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.
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.
Psychometric examination
Psychometric examination is carried out at the study centre with the help of a RIAS (Reynolds Intellectual Assessment Scales and Screening) test.
Recording of the adrenergic stress reaction (saliva test)
The adrenergic stress reaction is recorded by a saliva test.
Controls
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.
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.
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.
Psychometric examination
Psychometric examination is carried out at the study centre with the help of a RIAS (Reynolds Intellectual Assessment Scales and Screening) test.
Recording of the adrenergic stress reaction (saliva test)
The adrenergic stress reaction is recorded by a saliva test.
Interventions
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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.
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.
Psychometric examination
Psychometric examination is carried out at the study centre with the help of a RIAS (Reynolds Intellectual Assessment Scales and Screening) test.
Recording of the adrenergic stress reaction (saliva test)
The adrenergic stress reaction is recorded by a saliva test.
Eligibility Criteria
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Inclusion Criteria
* Written Informed Consent
* Singleton pregnancies
* Delivery at the University Hospital Jena
Exclusion Criteria
* 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
ALL
No
Sponsors
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Jena University Hospital
OTHER
Responsible Party
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Principal Investigators
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Friederike Weschenfelder, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Klinik für Geburtsmedizin
Locations
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Universitätsklinikum Jena
Jena, Thuringia, Germany
Countries
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Other Identifiers
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2019-1403
Identifier Type: -
Identifier Source: org_study_id
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