Gestational Diabetes

NCT ID: NCT04270578

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-23

Study Completion Date

2028-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with GDM

No interventions assigned to this group

Women without GDM

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Deutsches Diabeteszentrum (DDZ), Leibniz-Institut Düsseldorf

UNKNOWN

Sponsor Role collaborator

Medizinische Klinik und Poliklinik III, Universitätsklinikum Carl Gustav Carus, TU Dresden

UNKNOWN

Sponsor Role collaborator

Klinik für Diabetologie an der Medizinischen Klinik - Innenstadt, LMU München

UNKNOWN

Sponsor Role collaborator

Universitätsklinik Heidelberg, Abteilung Innere Medizin I, Schwerpunkt Endokrinologie und Stoffwechsel

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Leipzig, IFB Adipositas Erkrankungen

UNKNOWN

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Fritsche, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University Hospital Tuebingen

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andreas Fritsche, MD

Role: CONTACT

+49 7071 29 ext. 82711

Louise Fritsche, PhD

Role: CONTACT

+49 7071 29 ext. 82711

Facility Contacts

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Andreas Fritsche, MD

Role: primary

+49 7071 29 ext. 82711

Louise Fritsche, PhD

Role: backup

+49 7071 29 ext. 82711

References

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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.

Reference Type DERIVED
PMID: 35226999 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35180296 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35168986 (View on PubMed)

Other Identifiers

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218/2012BO2

Identifier Type: -

Identifier Source: org_study_id

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