Freder1k-Study - Testing Infants for Type 1 Diabetes Risk

September 21, 2023 updated by: Anette-Gabriele Ziegler, Helmholtz Zentrum München

Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials

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

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Estimated)

318000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

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.

Description

Inclusion Criteria:

  • Age: up to age 7 days
  • provided written informed consent by custodial parent

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes
Time Frame: one-time testing before age 7 days
increased risk will be identified by risk scores derived from SNPs
one-time testing before age 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helmholtz Zentrum München

Investigators

  • Study Chair: Anette-Gabriele Ziegler, Helmholtz Zentrum München, IDF-1

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2017

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (Actual)

October 20, 2017

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPPAD-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Identification of Infants at Risk for Type 1 Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe