Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy

NCT04417452 | Unknown

• 1 other identifier: 2019-1403
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes, Gestational; Pregnancy Diabetic

Outcome Measures

Primary Outcomes (4)

• 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

• Neurocognitive development

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

  1 day examination at the study centre

• 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

• Maturation of the gonadal regulation

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

  1 day examination at the study centre

Study Arms (2)

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

Basic data collection (online survey or written form) OTHER

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.

Controls; Mothers / children after diabetes in pregnancy

Physical examination OTHER

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.

Controls; Mothers / children after diabetes in pregnancy

Psychometric examination BEHAVIORAL

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

Controls; Mothers / children after diabetes in pregnancy

Recording of the adrenergic stress reaction (saliva test) DIAGNOSTIC_TEST

The adrenergic stress reaction is recorded by a saliva test.

Controls; Mothers / children after diabetes in pregnancy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• For the pilot project: Initial participation in the preliminary study
• Written Informed Consent
• Singleton pregnancies
• Delivery at the University Hospital Jena

You may not qualify if:

• 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

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (1)

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Friederike Weschenfelder, Dr. med.

  Klinik für Geburtsmedizin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: June 4, 2020
• Study Start: September 1, 2019
• Primary Completion: October 25, 2022
• Study Completion: December 31, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)