Offspring Exposed to GDM and ControlNCT04722900
PREG - Offspring: Investigation of Children From Mothers With and Without Gestational Diabetes
An observational study of Offspring Exposed to GDM and Control, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Gestational diabetes is the most common complication during pregrancy. With a screening between week 24 and 28 of gestation women with gestational diabetes can be identified and treated. Treatment comprises modification of diet and in some cases taking medication. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Offspring Exposed to GDM and Control
- What is being tested?
- intrauterine exposure to elevated glucose levels
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2021to 15 Sep 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Study participants are children from mothers that are enrolled in the PREG study.
Who may be able to join
- signed informed consent provided by child and parent
- documented oral glucose tolerance test of the mother during pregnancy
- adequate management of gestational diabetes until birth
Who cannot join
- severe malformation that makes an examination impossible
- existent of coagulation disorder with increased risk of bleeding after blood sampling
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen
Tübingen, 72076
Louise Fritsche
About this study
Official title: PREG-Offspring: Untersuchung Von Kindern Von Teilnehmerinnen Der Deutschen Studie Gestationsdiabetes (PREG-Studie)
Gestational diabetes is the most common complication during pregrancy. With a screening between week 24 and 28 of gestation women with gestational diabetes can be identified and treated. Treatment comprises modification of diet and in some cases taking medication. This treatment lowers undesirable events like macrosomia or premature birth. However, unitl gestational diabetes is diagnosed the fetus is exposed to increased intrauterine glucose levels. The long-term effects of a well-managed gestational diabetes on the development of the offspring is still not well understood. Therefore, the PREG - Offspring study investigates several aspects of development in children from healthy and gestational diabetes mothers until adulthood.
- Conditions
- Offspring Exposed to GDM and Control
- Being tested
- intrauterine exposure to elevated glucose levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrauterine exposure to elevated glucose levelsOther
intrauterine exposure to elevated glucose levels
| Study group | Role | What they receive |
|---|---|---|
| non-GDM | Not described | |
| GDM | Not described Receives: Other: intrauterine exposure to elevated glucose levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body height
Body height is measured with a tape measure in centimeter (cm)
Measured: Change in body height from birth to age 6, 10, 14 and 17
Secondary outcomes (10)
Body weight
Body weight is measured with a scale in kilogram (kg)
Measured: Change in body weight from birth to age 6, 10, 14 and 17
Body fat
Body fat content is measured with bioimpedance anaylsis in percent (%)
Measured: Change of body fat from age 6 to age 10, 14 and 17
Blood pressure
Blood pressure is measured with a blood pressure monitor as systolic and diastolic pressure in millimeter mercury column (mm Hg)
Measured: Change of blood pressure from age 6 to age 10, 14 and 17
Pubertal development scale
Pubertal development scale is assessed according to Tanner stages
Measured: Change of pubertal development scale from age 6 to age 10, 14 and 17
Blood glucose
Blood glucose is measured in blood sample in miligram per deciliter (mg/dl)
Measured: Change of blood glucose from age 6 to age 10, 14 and 17
HbA1C
HbA1C is measured in blood sample in percent (%)
Measured: Change of HbA1C from age 6 to age 10, 14 and 17
Cardiometabolic risk markers
Cholesterol, Low-density Lipoprotein, High-density Lipoprotein, Triglycerides, Lipoprotein(a) are measured in blood sample in mg/dl
Measured: Change of cardiometabolic risk markers from age 6 to 10, 14 and 17
Continuous glucose monitoring
24h glucose profiles and postprandial glycemic excursions (AUC) will be measured by flash glucose monitoring
Measured: Change of blood glucose from age 6 to age 10, 14 and 17
Activity level
Activity level is assessed with the MOMO activity questionnaire
Measured: Change of activity level from age 6 to 10, 14 and 17
Magnetic resonance imaging
Distribution of whole body fat and visceral and subcutaneous fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3T Whole Body Imager
Measured: Change of magnetic resonance images from age 6 to 10, 14 and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start15 Jan 2021
- Primary completion15 Jan 2036 (estimated)
- Study completion15 Sep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Offspring Exposed to GDM and ControlStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Fritsche, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722900
- Sponsor's protocol ID
- 617/2020BO1
- Status last verified
- Aug 2021
- First submitted
- 14 Jan 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fritsche L, Hummel J, Wagner R, Loffler D, Hartkopf J, Machann J, Hilberath J, Kantartzis K, Jakubowski P, Pauluschke-Frohlich J, Brucker S, Horber S, Haring HU, Roden M, Schurmann A, Solimena M, de Angelis MH, Peter A, Birkenfeld AL, Preissl H, Fritsche A, Heni M. The German Gestational Diabetes Study (PREG), a prospective multicentre cohort study: rationale, methodology and design. BMJ Open. 2022 Feb 15;12(2):e058268. doi: 10.1136/bmjopen-2021-058268.
PubMed 35168986
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREG-Offspring: Untersuchung Von Kindern Von Teilnehmerinnen Der Deutschen Studie Gestationsdiabetes (PREG-Studie)
- ClinicalTrials.gov ID
- NCT04722900
- Acronym / sponsor ID
- 617/2020BO1
- Conditions
- Offspring Exposed to GDM and Control
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Jan 2036 (estimated)
- Study completion
- 15 Sep 2036 (estimated)
- First posted
- 25 Jan 2021 (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.
Gestational diabetes is the most common complication during pregrancy. With a screening between week 24 and 28 of gestation women with gestational diabetes can be identified and treated. Treatment comprises modification of diet and in some cases taking medication. This treatment lowers undesirable events like macrosomia or premature birth. However, unitl gestational diabetes is diagnosed the fetus is exposed to increased intrauterine glucose levels. The long-term effects of a well-managed gestational diabetes on the development of the offspring is still not well understood. Therefore, the PREG - Offspring study investigates several aspects of development in children from healthy and gestational diabetes mothers until adulthood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-GDM | – | – |
| GDM | – | Other: intrauterine exposure to elevated glucose levels |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Study participants are children from mothers that are enrolled in the PREG study.
Key inclusion criteria (3 listed)
- signed informed consent provided by child and parent
- documented oral glucose tolerance test of the mother during pregnancy
- adequate management of gestational diabetes until birth
Key exclusion criteria (2 listed)
- severe malformation that makes an examination impossible
- existent of coagulation disorder with increased risk of bleeding after blood sampling
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 |
|---|---|---|
| intrauterine exposure to elevated glucose levelsintrauterine exposure to elevated glucose levels | Other | GDM |
Primary outcome
Body height
Time frame: Change in body height from birth to age 6, 10, 14 and 17
Body height is measured with a tape measure in centimeter (cm)
10 secondary outcomes
Body weight
Time frame: Change in body weight from birth to age 6, 10, 14 and 17
Body fat
Time frame: Change of body fat from age 6 to age 10, 14 and 17
Blood pressure
Time frame: Change of blood pressure from age 6 to age 10, 14 and 17
Pubertal development scale
Time frame: Change of pubertal development scale from age 6 to age 10, 14 and 17
Blood glucose
Time frame: Change of blood glucose from age 6 to age 10, 14 and 17
HbA1C
Time frame: Change of HbA1C from age 6 to age 10, 14 and 17
Cardiometabolic risk markers
Time frame: Change of cardiometabolic risk markers from age 6 to 10, 14 and 17
Continuous glucose monitoring
Time frame: Change of blood glucose from age 6 to age 10, 14 and 17
Activity level
Time frame: Change of activity level from age 6 to 10, 14 and 17
Magnetic resonance imaging
Time frame: Change of magnetic resonance images from age 6 to 10, 14 and 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Derived from this study: PubMed 35168986Fritsche L, Hummel J, Wagner R, Loffler D, Hartkopf J, Machann J, Hilberath J, Kantartzis K, Jakubowski P, Pauluschke-Frohlich J, Brucker S, Horber S, Haring HU, Roden M, Schurmann A, Solimena M, de Angelis MH, Peter A, Birkenfeld AL, Preissl H, Fritsche A, Heni M. The German Gestational Diabetes Study (PREG), a prospective multicentre cohort study: rationale, methodology and design. BMJ Open. 2022 Feb 15;12(2):e058268. doi: 10.1136/bmjopen-2021-058268.
- Individual participant dataSharing planned: No
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.
Andreas Fritsche principal investigator
University Hospital Tuebingen
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 Offspring Exposed to GDM and Control, run by University Hospital Tuebingen 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Sep 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Fritsche, Dr. rer. nat. (07071-2980687, louise.fritsche@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body height (time frame: Change in body height from birth to age 6, 10, 14 and 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722900, which also lists 1 linked publication.
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 2 Sep 2021.