Actively Recruiting

Age: 2Years - 45Years
All Genders
Healthy Volunteers
NCT06665815

A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients

Led by Rabin Medical Center · Updated on 2025-05-20

20000

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A national Screening program for the presence of Islet Autoantibodies (IA) in relatives of people with type 1 diabetes (PWT1D) aiming at identifying people with pre-clinical (stage 1 \& 2) T1D and DKA prevention on the clinical presentation of T1D. All participants will be screened at study entry for the presence of 4 islet autoantibodies: glutamic acid decarboxylase antibody (GADA), insulinoma-associated-2 antibody (IA-2A), insulin antibodies (IAA) and Zinc transporter-8 antibodies (ZnT8A). The ADAP assay will be used to detect IA. A confirmation blood sample for positive participants with two or more IA will be taken. The confirmation analysis will be done by the ADAP assay, conventional ELISA, and RIA. Participants identified as part of the study with pre-symptomatic type 1 diabetes (T1D) (stages 1 and 2) will be referred to complete an educational program emphasizing DKA prevention as part of routine medical care .During the study, cases of stage 2 and stage 3 diabetes and DKA events in participants who are positive for IA will be documented.

CONDITIONS

Official Title

A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients

Who Can Participate

Age: 2Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 2 to 45 years
  • First-degree relatives of Type 1 Diabetes probands
  • Signing an informed consent
Not Eligible

You will not qualify if you...

  • Known diabetes of any kind (type 1, type 2, MODY)
  • Previous treatment with insulin or oral diabetes medications
  • Current use of systemic immunosuppressive agents (topical and inhaled agents allowed)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Schneider Children Medical Center of Israel

Petah Tikva, Israel

Actively Recruiting

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Research Team

M

Moshe Phillip, Prof.

CONTACT

A

Alona Hamou, Msc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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