A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-45
SponsorRabin Medical Center
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age 2-45 years
First-degree relatives of Type 1 Diabetes probands
Signing an informed consent
Disqualifiers
Known diabetes of any kind (type 1, type 2, MODY)
Have a previous history of being treated with insulin or oral diabetes medications.
Currently, using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
Trial population
First degree relatives of patients with Type 1 diabetes from all over Israel, aged 2-45 years old
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20,000 Participants
are grouped into 2 trial groupsGroup A: Negative result at the autoantibodies screening test
Group B: Positive result at the autoantibodies screening test
Trial outcomes
Primary outcomes
1
The prevalence of multiple antibodies among first-degree relatives of Type I Diabetes probands in Israel
Time frame
End of screening, 3 years after obtaining the first screening testSecondary outcomes
1
The prevalence of Diabetic Ketoacidosis at Type 1 Diabetes presentation among the screened cohort
Time frame
End of screening, 3 years after obtaining the first screening test2
Proportion and rate of progression from stage 1 to stage 2 and stage 3 Type 1 Diabetes
Time frame
End of screening, 3 years after obtaining the first screening test3
>500 individuals with pre-clinical Type 1 Diabetes identified in the cohort
Time frame
End of screening, 3 years after obtaining the first screening testSponsors and contacts
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Source ClinicalTrials.gov