PREG - Offspring: Investigation of Children From Mothers With and Without Gestational Diabetes

NCT ID: NCT04722900

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-15

Study Completion Date

2036-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Offspring Exposed to GDM and Control

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non-GDM

No interventions assigned to this group

GDM

intrauterine exposure to elevated glucose levels

Intervention Type OTHER

intrauterine exposure to elevated glucose levels

Interventions

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intrauterine exposure to elevated glucose levels

intrauterine exposure to elevated glucose levels

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* severe malformation that makes an examination impossible
* existent of coagulation disorder with increased risk of bleeding after blood sampling
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Fritsche

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Locations

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University Hospital Tübingen

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Louise Fritsche, Dr. rer. nat.

Role: CONTACT

07071-2980687

Facility Contacts

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Louise Fritsche

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35168986 (View on PubMed)

Other Identifiers

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617/2020BO1

Identifier Type: -

Identifier Source: org_study_id

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