CClinicalTrials.gg
Status unknownNCT04417452MuKiLOGUpdated Apr 14, 2023

Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy

An observational study in Diabetes, Gestational and Pregnancy Diabetic, sponsored by Jena University Hospital. Status unknown at 1 site in Germany. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by Jena University Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Diabetes, Gestational
  • Pregnancy Diabetic
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 269 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Jena University Hospital is the lead sponsor of 62 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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 independently 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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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

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

Interventions

  • OtherBasic 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.

  • OtherPhysical 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.

  • BehavioralPsychometric examination

    Psychometric examination is carried out at the study centre with the help of a RIAS (Reynolds Intellectual Assessment Scales and Screening) test.

  • Diagnostic testRecording of the adrenergic stress reaction (saliva test)

    The adrenergic stress reaction is recorded by a saliva test.

06

What researchers measure

Primary outcomes

  1. Metabolic health

    effects on metabolic health such as glucose tolerance disorders and diabetes mellitus, obesity and metabolic syndrome (mothers and children)

    Time frame: 1 day examination at the study centre

  2. Neurocognitive development

    effects on neurocognitive development, mental health and adrenal and autonomic stress reactivity (mothers and children)

    Time frame: 1 day examination at the study centre

  3. Cardiovascular and vascular health

    effects on cardiovascular and vascular health of blood pressure regulation and endothelial function (mothers and children)

    Time frame: 1 day examination at the study centre

  4. Maturation of the gonadal regulation

    maturation of gonadal regulation, pubertal development and reproductive health (children)

    Time frame: 1 day examination at the study centre

07

Study locations

1 site
  • Universitätsklinikum Jena
    Jena, Thüringen 07747, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04417452
Lead sponsor
Jena University Hospital
Responsible party
Sponsor
First posted
Jun 4, 2020
Start date
Sep 1, 2019
Primary completion
Oct 25, 2022
Completion
Dec 31, 2023 (estimated)
Last update
Apr 14, 2023

Study contacts

Friederike Weschenfelder, Dr. med.
principal investigator · Klinik für Geburtsmedizin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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