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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04417452
Acronym
MuKiLOG
Enrollment
100
Registered
2020-06-04
Start date
2019-09-01
Completion date
2023-12-31
Last updated
2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational, Pregnancy Diabetic

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

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.

Sponsors

Jena University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Metabolic health1 day examination at the study centreeffects on metabolic health such as glucose tolerance disorders and diabetes mellitus, obesity and metabolic syndrome (mothers and children)
Neurocognitive development1 day examination at the study centreeffects on neurocognitive development, mental health and adrenal and autonomic stress reactivity (mothers and children)
Cardiovascular and vascular health1 day examination at the study centreeffects on cardiovascular and vascular health of blood pressure regulation and endothelial function (mothers and children)
Maturation of the gonadal regulation1 day examination at the study centrematuration of gonadal regulation, pubertal development and reproductive health (children)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026