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Recruiting NCT04270578

Gestational Diabetes

— Observational Gestational Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gestational Diabetes. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

German Study Gestational Diabetes (PREG)

Overview

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.

Primary outcome measures

  • Glucose tolerance during 75 g oral glucose tolerance test [Time frame: Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)]
Secondary outcome measures (10)
  • Glucose tolerance during 75 g oral glucose tolerance test 1, 2, 5, 10 years postpartum [Time frame: Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)]
  • Body fat distribution [Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum]
  • Spiroergometry to assess physical fitness [Time frame: 1, 2, 5, and 10 years postpartum]
  • BIA (bioimpedance analysis) [Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum]
  • BMI [Time frame: Once during pregnancy and 1, 2, 5, and 10 years postpartum]
  • Assessment of cognitive abilities in offspring [Time frame: 6 and 10 years postpartum]
  • Assessment of cognitive, motoric and language development in offspring [Time frame: 2 years postpartum]
  • BIA in offspring [Time frame: 2, 6 and 10 years postpartum]
  • Electrocardiogram [Time frame: 2, 6 and 10 years postpartum]
  • blood sample [Time frame: 6 and 10 years postpartum]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Germany · 1 center
  • University Hospital Tuebingen — Tübingen

Publications

  • 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. PMID 35226999
  • 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. PMID 35180296
  • 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. 202 PMID 35168986

Identifiers

NCT: NCT04270578 · 218/2012BO2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗