Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy (MuKiLOG)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes, Gestational; Pregnancy Diabetic
• Intervention / Treatment: Other: Basic data collection (online survey or written form); Other: Physical examination; Diagnostic test: Recording of the adrenergic stress reaction (saliva test); Behavioral: Psychometric examination

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Germany
  • Thüringen
    • Jena, Thüringen, Germany, 07747
      • Universitatsklinikum Jena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.; Other: 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.; Diagnostic test: Recording of the adrenergic stress reaction (saliva test); The adrenergic stress reaction is recorded by a saliva test.; 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.
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); 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.; Other: 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.; Diagnostic test: Recording of the adrenergic stress reaction (saliva test); The adrenergic stress reaction is recorded by a saliva test.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Investigators: Principal Investigator: Friederike Weschenfelder, Dr. med., Klinik für Geburtsmedizin

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): October 25, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents
• Other Study ID Numbers: 2019-1403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No