Study Results
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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RECRUITING
800 participants
OBSERVATIONAL
2012-05-23
2028-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Women with GDM
No interventions assigned to this group
Women without GDM
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Enrollment is possible during AND after gestation:
* Baseline visit (pregnancy): gestational week 24+0 till 31+6
* Postpartum visits: documented occurence of GDM in previous pregnancy
Exclusion Criteria
* Diabetes Mellitus Type 1 or Type 2
* GFR \< 60 ml/min/1,73 m2
* CRP \> 1 mg/dl
* Increased levels of transaminases 2 fold above ULN
* Preexisting cardiac conditions
* Weight loss \> 10% within 6 months prior to inclusion
* Psychiatric disorders
* Chronic alcohol or substance abuse
* Blood sugar increasing or decreasing drug therapy, e.g. steroids, antidiabetics, insulin
* only postpartum visits: pregnancy or lactation
18 Years
FEMALE
Yes
Sponsors
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Deutsches Diabeteszentrum (DDZ), Leibniz-Institut Düsseldorf
UNKNOWN
Medizinische Klinik und Poliklinik III, Universitätsklinikum Carl Gustav Carus, TU Dresden
UNKNOWN
Klinik für Diabetologie an der Medizinischen Klinik - Innenstadt, LMU München
UNKNOWN
Universitätsklinik Heidelberg, Abteilung Innere Medizin I, Schwerpunkt Endokrinologie und Stoffwechsel
UNKNOWN
Universitätsklinikum Leipzig, IFB Adipositas Erkrankungen
UNKNOWN
University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Andreas Fritsche, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Tuebingen
Locations
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University Hospital Tuebingen
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Bauer I, Schleger F, Hartkopf J, Veit R, Breuer M, Schneider N, Pauluschke-Frohlich J, Peter A, Preissl H, Fritsche A, Fritsche L. Pre-pregnancy BMI but not mild stress directly influences Interleukin-6 levels and insulin sensitivity during late pregnancy. Front Biosci (Landmark Ed). 2022 Feb 12;27(2):56. doi: 10.31083/j.fbl2702056.
Fritsche L, Heni M, Eckstein SS, Hummel J, Schurmann A, Haring HU, Preissl H, Birkenfeld AL, Peter A, Fritsche A, Wagner R. Incretin Hypersecretion in Gestational Diabetes Mellitus. J Clin Endocrinol Metab. 2022 May 17;107(6):e2425-e2430. doi: 10.1210/clinem/dgac095.
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.
Other Identifiers
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218/2012BO2
Identifier Type: -
Identifier Source: org_study_id
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