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NCT Number: NCT03316261

Freder1k-Study - Testing Infants for Type 1 Diabetes Risk

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

Recruiting

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Key information

Conditions

Identification of Infants at Risk for Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 day–6 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut für Diabetesforschung, Helmholtz Zentrum München

Munich, Germany

Location status: Recruiting

Location contact

Anette-G. Ziegler, Prof. Dr.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes

    Time frame: one-time testing before age 6 weeks

    increased risk will be identified by risk scores derived from SNPs

Study contacts

Contact information is provided by the study sponsor or research team.

Anette-Gabriele Ziegler

CONTACT

[email protected]

0800-000 0018

Christiane Winkler

CONTACT

[email protected]

0049-89-31873745

Sponsors and collaborators

Lead sponsor

Helmholtz Zentrum München

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2017
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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