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

• Published in: BMJ open 2022-02, Vol.12 (2), p.e058268
• Main Authors: Fritsche, Louise, Hummel, Julia, Wagner, Robert, Löffler, Dorina, Hartkopf, Julia, Machann, Jürgen, Hilberath, Johannes, Kantartzis, Konstantinos, Jakubowski, Peter, Pauluschke-Fröhlich, Jan, Brucker, Sara, Hörber, Sebastian, Häring, Hans-Ulrich, Roden, Michael, Schürmann, Annette, Solimena, Michele, de Angelis, Martin Hrabe, Peter, Andreas, Birkenfeld, Andreas L, Preissl, Hubert, Fritsche, Andreas, Heni, Martin
• Format: Article
• Language: English
• Subjects: Adult; Blood Glucose - metabolism; Brain research; Child; Child development; Children & youth; Cohort analysis; Diabetes and Endocrinology; diabetes in pregnancy; Diabetes, Gestational - therapy; Female; Fetuses; Gestational diabetes; Glucose; Glucose Tolerance Test; Humans; Hyperglycemia; Insulin resistance; Intelligence tests; Male; maternal medicine; Metabolism; Mothers; Obesity; Outpatient care facilities; Pregnancy; Prospective Studies; Public health; Spectrum analysis; Womens health
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2021-058268

IntroductionEven 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.MethodsThe 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 disseminationThe study protocol has been approved by all local ethics committees. Results will be disseminated via conference presentations and peer-reviewed publications.Trial registration numberThe PREG study and the PREG Offspring study are registered with Clinical Trials (ClinicalTrials.gov identifiers: NCT04270578, NCT04722900).