Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy

Diabetes, Gestational Clinical Trial

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Official title:

Effects of Fetal Programming on the Metabolic, Cardiovascular, Neurocognitive and Reproductive Health of Offsprings and Their Mothers After Pregnancies With Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04417452
• Other study ID #: 2019-1403
• Status: Active, not recruiting
• Start date: September 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Pregnancy Diabetic
• Pregnancy in Diabetics

Intervention

Other:
• 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.

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

Diagnostic Test:
• Recording of the adrenergic stress reaction (saliva test)
The adrenergic stress reaction is recorded by a saliva test.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Jena	Jena	Thüringen

Sponsors (1)

Lead Sponsor	Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic health	effects on metabolic health such as glucose tolerance disorders and diabetes mellitus, obesity and metabolic syndrome (mothers and children)	1 day examination at the study centre
Primary	Neurocognitive development	effects on neurocognitive development, mental health and adrenal and autonomic stress reactivity (mothers and children)	1 day examination at the study centre
Primary	Cardiovascular and vascular health	effects on cardiovascular and vascular health of blood pressure regulation and endothelial function (mothers and children)	1 day examination at the study centre
Primary	Maturation of the gonadal regulation	maturation of gonadal regulation, pubertal development and reproductive health (children)	1 day examination at the study centre