Clinical trial NCT04270578: Gestational Diabetes
Official title: German Study Gestational Diabetes (PREG)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes
Keywords: gestational diabetes
insulin
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Deutsches Diabeteszentrum (DDZ), Leibniz-Institut Düsseldorf
name: Medizinische Klinik und Poliklinik III, Universitätsklinikum Carl Gustav Carus, TU Dresden
name: Klinik für Diabetologie an der Medizinischen Klinik - Innenstadt, LMU München
name: Universitätsklinik Heidelberg, Abteilung Innere Medizin I, Schwerpunkt Endokrinologie und Stoffwechsel
name: Universitätsklinikum Leipzig, IFB Adipositas Erkrankungen
First posted: 2020-02-17
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women in gestational week 24+0 till 31+6 and women postpartum who had a documented occurence of GDM in previous pregnancy.

Brief summary: Due to a changed lifestyle with less physical activity, unfavorable diets rich in fat and calories and obesity, the prevalence of diabetes mellitus is increasing worldwide. The diabetes epidemic is associated with significant personal and socio-economic consequences. Despite attempts to prevent the complications of diabetes, this disease is still the leading cause of blindness, chronic renal insufficiency and non-traumatic amputation. It is important to detect early on an increase in blood sugar and treat it accordingly to reduce costs and to minimize the personal suffering of those affected. As the number of patients with type 2 diabetes mellitus continues to rise, the number of young women with gestational diabetes mellitus (GDM) also increases. This is a disorder og glucose metabolism, which occurs for the first time in pregnancy. The causes for this are manifold. Among other causes, the increasing age of the mothers and weight gain during pregnancy are risk factors for gestational diabetes. Although it has been recommended that women with gestational diabetes should be re-examined after the birth of their child, many women have not. The study is a follow-up study to clarify whether insulin secretion disorder in women with and after GDM is a risk factor for the occurrence of type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

- Signed and dated informed consent

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:

* Age \< 18years
* 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

Primary outcomes:
measure: Glucose tolerance during 75 g oral glucose tolerance test
timeFrame: Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)
Secondary outcomes:
measure: Glucose tolerance during 75 g oral glucose tolerance test 1, 2, 5, 10 years postpartum
timeFrame: Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)
measure: Body fat distribution
timeFrame: Once during pregnancy and 1, 2, 5, and 10 years postpartum
measure: Spiroergometry to assess physical fitness
timeFrame: 1, 2, 5, and 10 years postpartum
measure: BIA (bioimpedance analysis)
timeFrame: Once during pregnancy and 1, 2, 5, and 10 years postpartum
measure: BMI
timeFrame: Once during pregnancy and 1, 2, 5, and 10 years postpartum
measure: Assessment of cognitive abilities in offspring
timeFrame: 6 and 10 years postpartum
measure: Assessment of cognitive, motoric and language development in offspring
timeFrame: 2 years postpartum
measure: BIA in offspring
timeFrame: 2, 6 and 10 years postpartum
measure: Electrocardiogram
timeFrame: 2, 6 and 10 years postpartum
measure: blood sample
timeFrame: 6 and 10 years postpartum
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Andreas Fritsche, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.