Gestational Diabetes (PREG)

German Study Gestational Diabetes (PREG)

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • Recruiting
    • University Hospital Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Women with GDM
Women without GDM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose tolerance during 75 g oral glucose tolerance test	Glucose tolerance, insulin sensitivity and insulin secretion during oral glucose tolerance test	Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose tolerance during 75 g oral glucose tolerance test 1, 2, 5, 10 years postpartum	Glucose tolerance during oral glucose tolerance test	Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)
Body fat distribution	Measurement of body fat distribution by MRS	Once during pregnancy and 1, 2, 5, and 10 years postpartum
Spiroergometry to assess physical fitness	Measurement of VO2max (l/min/kg) as a proxy for physical fitness	1, 2, 5, and 10 years postpartum
BIA (bioimpedance analysis)	BIA to estimate body fat (%)	Once during pregnancy and 1, 2, 5, and 10 years postpartum
BMI	Measurement of weight (kg) and height (m) and given as kg/m^2	Once during pregnancy and 1, 2, 5, and 10 years postpartum
Assessment of cognitive abilities in offspring	Cognitive skills represented as an intelligence quotient will be assessed Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V)	6 and 10 years postpartum
Assessment of cognitive, motoric and language development in offspring	Cognitive, motoric and language development of children will be assessed with the Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III)	2 years postpartum
BIA in offspring	BIA to estimate body composition in offspring	2, 6 and 10 years postpartum
Electrocardiogram	10 minute ECG to assess RR distance for calculation of heart rate variability (R wave distance in ms)	2, 6 and 10 years postpartum
blood sample	blood sample to assess HbA1C	6 and 10 years postpartum

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Deutsches Diabeteszentrum (DDZ), Leibniz-Institut Düsseldorf; Medizinische Klinik und Poliklinik III, Universitätsklinikum Carl Gustav Carus, TU Dresden; Klinik für Diabetologie an der Medizinischen Klinik - Innenstadt, LMU München; Universitätsklinik Heidelberg, Abteilung Innere Medizin I, Schwerpunkt Endokrinologie und Stoffwechsel; Universitätsklinikum Leipzig, IFB Adipositas Erkrankungen

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 23, 2012
• Primary Completion (ANTICIPATED): May 1, 2027
• Study Completion (ANTICIPATED): May 1, 2028

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: insulin; gestational diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 218/2012BO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No