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Freder1k-Study - Testing Infants for Type 1 Diabetes Risk

NCT ID: NCT03316261

Last Updated: 2024-12-17

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

1000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-19

Study Completion Date

2027-08-31

Brief Summary

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The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.

Detailed Description

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Type 1 diabetes is a common chronic disease in childhood and is increasing in incidence. Type 1 diabetes is diagnosed by hyperglycemia often in combination with symptoms of weight loss, thirst, fatigue and frequent urination, sometimes with ketoacidosis. The clinical onset is preceded by an asymptomatic phase identified by serum multiple beta-cell autoantibodies. Neonates and infants who are at increased risk to develop multiple beta-cell autoantibodies and type 1 diabetes can now be identified using genetic markers. This provides opportunity for introducing early therapies to prevent beta-cell autoimmunity and type 1 diabetes.

Conditions

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Identification of Infants at Risk for Type 1 Diabetes

Keywords

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infants type 1 diabetes Freder1k

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Age: up to age 6 weeks
* provided written informed consent by custodial parent

Exclusion Criteria

\-
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helmholtz Zentrum München

INDUSTRY

Sponsor Role lead

Responsible Party

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Anette-Gabriele Ziegler

Director - Institute of Diabetes Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anette-Gabriele Ziegler

Role: STUDY_CHAIR

Helmholtz Zentrum München, IDF-1

Locations

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Institut für Diabetesforschung, Helmholtz Zentrum München

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Anette-Gabriele Ziegler

Role: CONTACT

Phone: 0800-000 0018

Email: [email protected]

Christiane Winkler

Role: CONTACT

Phone: 0049-89-31873745

Email: [email protected]

Facility Contacts

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Anette-G. Ziegler, Prof. Dr.

Role: primary

References

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Hippich M, Holthaus L, Assfalg R, Zapardiel-Gonzalo J, Kapfelsperger H, Heigermoser M, Haupt F, Ewald DA, Welzhofer TC, Marcus BA, Heck S, Koelln A, Stock J, Voss F, Secchi M, Piemonti L, de la Rosa K, Protzer U, Boehmer M, Achenbach P, Lampasona V, Bonifacio E, Ziegler AG. A Public Health Antibody Screening Indicates a 6-Fold Higher SARS-CoV-2 Exposure Rate than Reported Cases in Children. Med. 2021 Feb 12;2(2):149-163.e4. doi: 10.1016/j.medj.2020.10.003. Epub 2020 Oct 29.

Reference Type DERIVED
PMID: 33163984 (View on PubMed)

Related Links

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http://www.gppad.org

GPPAD

Other Identifiers

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GPPAD-02

Identifier Type: -

Identifier Source: org_study_id