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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 45
Healthy Volunteers: t
View:

• Age 2-45 years

• First-degree relatives of Type 1 Diabetes probands

• Signing an informed consent

Locations
Other Locations
Israel
Schneider Children Medical Center of Israel
RECRUITING
Petah Tikva
Contact Information
Primary
Moshe Phillip, Prof.
moshe.phillip@phillipmd.com
972-544-795995
Backup
Alona Hamou, Msc
alonah@clalit.org.il
972-545-950277
Time Frame
Start Date: 2024-12-15
Estimated Completion Date: 2028-02-15
Participants
Target number of participants: 20000
Treatments
Negative result at the autoantibodies screening test
1. Participants without positive autoantibodies will not be confirmed or referred to follow up~2. Participants with only one positive autoantibody, will be referred to perform regular follow up as part of routine medical care according to the international consensus guidelines published in July 2024
Positive result at the autoantibodies screening test
Participants with two or more positive autoantibodies:~1. will be invited to perform a confirmation test as part of the study~2. If confirmed as having pre-symptomatic type 1 diabetes (T1D) (stages 1 / 2), participants will be referred to complete an educational program emphasizing on DKA prevention and to perform regular follow-up according to the international consensus guidelines published in July 2024, as part of routine medical care
Related Therapeutic Areas
Sponsors
Leads: Rabin Medical Center

This content was sourced from clinicaltrials.gov