Gestational Diabetes

NCT04270578 | Recruiting

• 1 other identifier: 218/2012BO2
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

gestational diabetes; insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Glucose tolerance during 75 g oral glucose tolerance test 1, 2, 5, 10 years postpartum

  Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)

• Body fat distribution

  Once during pregnancy and 1, 2, 5, and 10 years postpartum

• Spiroergometry to assess physical fitness

  1, 2, 5, and 10 years postpartum

• BIA (bioimpedance analysis)

  Once during pregnancy and 1, 2, 5, and 10 years postpartum

• BMI

  Once during pregnancy and 1, 2, 5, and 10 years postpartum

Study Arms (2)

Women with GDM

Women without GDM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (3)

• 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 DERIVED

• 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 DERIVED

• 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.

  PMID: 35168986 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Andreas Fritsche, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Fritsche, MD

CONTACT

+49 7071 29; andreas.fritsche@med.uni-tuebingen.de

Louise Fritsche, PhD

CONTACT

+49 7071 29; louise.fritsche@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: February 17, 2020
• Study Start: May 23, 2012
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)