The German Gestational Diabetes Study (PREG), a prospective multicentre cohort study: rationale, methodology and design

Louise Fritsche, Julia Hummel, Robert Wagner, Dorina Löffler, Julia Hartkopf, Jürgen Machann, Johannes Hilberath, Konstantinos Kantartzis, Peter Jakubowski, Jan Pauluschke-Fröhlich, Sara Brucker, Sebastian Hörber, Hans-Ulrich Häring, Michael Roden, Annette Schürmann, Michele Solimena, Martin Hrabe de Angelis, Andreas Peter, Andreas L Birkenfeld, Hubert Preissl, Andreas Fritsche, Martin Heni, Louise Fritsche, Julia Hummel, Robert Wagner, Dorina Löffler, Julia Hartkopf, Jürgen Machann, Johannes Hilberath, Konstantinos Kantartzis, Peter Jakubowski, Jan Pauluschke-Fröhlich, Sara Brucker, Sebastian Hörber, Hans-Ulrich Häring, Michael Roden, Annette Schürmann, Michele Solimena, Martin Hrabe de Angelis, Andreas Peter, Andreas L Birkenfeld, Hubert Preissl, Andreas Fritsche, Martin Heni

Abstract

Introduction: Even well-treated gestational diabetes mellitus (GDM) might still have impact on long-term health of the mother and her offspring, although this relationship has not yet been conclusively studied. Using in-depth phenotyping of the mother and her offspring, we aim to elucidate the relationship of maternal hyperglycaemia during pregnancy and adequate treatment, and its impact on the long-term health of both mother and child.

Methods: The multicentre PREG study, a prospective cohort study, is designed to metabolically and phenotypically characterise women with a 75-g five-point oral glucose tolerance test (OGTT) during, and repeatedly after pregnancy. Outcome measures are maternal glycaemia during OGTTs, birth outcome and the health and growth development of the offspring. The children of the study participants are followed up until adulthood with developmental tests and metabolic and epigenetic phenotyping in the PREG Offspring study. A total of 800 women (600 with GDM, 200 controls) will be recruited.

Ethics and dissemination: The study protocol has been approved by all local ethics committees. Results will be disseminated via conference presentations and peer-reviewed publications.

Trial registration number: The PREG study and the PREG Offspring study are registered with Clinical Trials (ClinicalTrials.gov identifiers: NCT04270578, NCT04722900).

Keywords: diabetes in pregnancy; maternal medicine; public health.

Conflict of interest statement

Competing interests: RW reports lecture fees from Novo Nordisk and travel grants from Eli Lilly. He served on the advisory board of Akcea Therapeutics. In addition to his current work, ALB reports lecture fees from Astra Zeneca, Boehringer Ingelheim and NovoNordisk. He also served on advisory boards of Astra Zeneca, Boehringer Ingelheim and Novo Nordisk. Besides his current work, AF reports lecture fees and advisory board membership from Sanofi, Novo Nordisk, Eli Lilly and Astra Zeneca. In addition to his current work, MH reports research grants from Boehringer Ingelheim and Sanofi (both to the University Hospital of Tübingen) and lecture fees from Amryt, Sanofi, Novo Nordisk, Eli Lilly and Merck Sharp Dohme. He served on an advisory board for Boehringer Ingelheim. MR serves on advisory board and/or received lecture fees from Boehringer-Ingelheim Pharma, Eli Lilly, Fishawack Group, Novo Nordisk, Sanofi US, Target NASH and Terra Firma, as well as investigator-initiated research support from Boehringer-Ingelheim, Nutricia/Danone and Sanofi-Aventis.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study outline.

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