Freder1k-Study - Testing Infants for Type 1 Diabetes Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03316261
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : February 23, 2018
Information provided by (Responsible Party):
Anette-Gabriele Ziegler, Helmholtz Zentrum München

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

Condition or disease
Identification of Infants at Risk for Type 1 Diabetes

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 168000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Primary Outcome Measures :
  1. greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes [ Time Frame: one-time testing before age 4 months ]
    increased risk will be identified by risk scores derived from SNPs

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.

Inclusion Criteria:

  • Age: up to age 4 months
  • provided written informed consent by custodial parent

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03316261

Contact: Anette-Gabriele Ziegler, Prof. Dr. med. 0800-000 0018

Institut für Diabetesforschung, Helmholtz Zentrum München Recruiting
Munich, Germany
Contact: Anette-G. Ziegler, Prof. Dr.         
Sponsors and Collaborators
Helmholtz Zentrum München

Additional Information:
Responsible Party: Anette-Gabriele Ziegler, Director - Institute of Diabetes Research, Helmholtz Zentrum München Identifier: NCT03316261     History of Changes
Other Study ID Numbers: GPPAD-02
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anette-Gabriele Ziegler, Helmholtz Zentrum München:
type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases