Diabetes, GestationalMuKiLOGNCT04417452
Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy
An observational study of Diabetes, Gestational and Pregnancy Diabetic, run by Jena University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Gestational, Pregnancy Diabetic
- What is being tested?
- Basic data collection (online survey or written form), Physical examination and Psychometric examination
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- For the pilot project: Initial participation in the preliminary study
- Written Informed Consent
- Singleton pregnancies
- Delivery at the University Hospital Jena
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Conditions
- Diabetes, Gestational, Pregnancy Diabetic
- Being tested
- Basic data collection (online survey or written form), Physical examination, Psychometric examination, Recording of the adrenergic stress reaction (saliva test)
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Physical examinationOther
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.
Psychometric examinationBehavioural
Psychometric examination is carried out at the study centre with the help of a RIAS (Reynolds Intellectual Assessment Scales and Screening) test.
Recording of the adrenergic stress reaction (saliva test)Diagnostic test
The adrenergic stress reaction is recorded by a saliva test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic health
effects on metabolic health such as glucose tolerance disorders and diabetes mellitus, obesity and metabolic syndrome (mothers and children)
Measured: 1 day examination at the study centre
Neurocognitive development
effects on neurocognitive development, mental health and adrenal and autonomic stress reactivity (mothers and children)
Measured: 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)
Measured: 1 day examination at the study centre
Maturation of the gonadal regulation
maturation of gonadal regulation, pubertal development and reproductive health (children)
Measured: 1 day examination at the study centre
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Sep 2019
- Primary completion25 Oct 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Friederike Weschenfelder, Dr. med., Principal investigator, Klinik für Geburtsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417452
- Sponsor's protocol ID
- 2019-1403
- Acronym
- MuKiLOG
- Status last verified
- Apr 2023
- First submitted
- 15 Apr 2020
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fetal Programming on the Metabolic, Cardiovascular, Neurocognitive and Reproductive Health of Offsprings and Their Mothers After Pregnancies With Diabetes
- ClinicalTrials.gov ID
- NCT04417452
- Acronym / sponsor ID
- MuKiLOG / 2019-1403
- Conditions
- Diabetes, Gestational, Pregnancy Diabetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers / children after diabetes in pregnancy | – | 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)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. |
| Controls | – | 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)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- For the pilot project: Initial participation in the preliminary study
- Written Informed Consent
- Singleton pregnancies
- Delivery at the University Hospital Jena
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Controls, Mothers / children after diabetes in pregnancy |
| Physical examinationThe 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. | Other | Controls, Mothers / children after diabetes in pregnancy |
| Psychometric examinationPsychometric examination is carried out at the study centre with the help of a RIAS (Reynolds Intellectual Assessment Scales and Screening) test. | Behavioural | Controls, Mothers / children after diabetes in pregnancy |
| Recording of the adrenergic stress reaction (saliva test)The adrenergic stress reaction is recorded by a saliva test. | Diagnostic test | Controls, Mothers / children after diabetes in pregnancy |
Primary outcome
Metabolic health
Time frame: 1 day examination at the study centre
effects on metabolic health such as glucose tolerance disorders and diabetes mellitus, obesity and metabolic syndrome (mothers and children)
Neurocognitive development
Time frame: 1 day examination at the study centre
effects on neurocognitive development, mental health and adrenal and autonomic stress reactivity (mothers and children)
Cardiovascular and vascular health
Time frame: 1 day examination at the study centre
effects on cardiovascular and vascular health of blood pressure regulation and endothelial function (mothers and children)
Maturation of the gonadal regulation
Time frame: 1 day examination at the study centre
maturation of gonadal regulation, pubertal development and reproductive health (children)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friederike Weschenfelder, Dr. med. principal investigator
Klinik für Geburtsmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, Gestational and Pregnancy Diabetic, run by Jena University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic health (time frame: 1 day examination at the study centre). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.