Freder1k-Study - Testing Infants for Type 1 Diabetes Risk

Identification of Infants at Risk for Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03316261
• Other study ID #: GPPAD-02
• Status: Recruiting
• Start date: October 19, 2017
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Helmholtz Zentrum München
• Contact: Anette-Gabriele Ziegler
• Phone: 0800-000 0018
• Email: contact[@]gppad.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318000
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 7 Days

Eligibility

Inclusion Criteria:

• Age: up to age 7 days

• provided written informed consent by custodial parent

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Identification of Infants at Risk for Type 1 Diabetes

Locations

Country	Name	City	State
Germany	Institut für Diabetesforschung, Helmholtz Zentrum München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Helmholtz Zentrum München

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   GPPAD