The Israeli Study for Islet Autoantibodies Screening in Families of Type-1 Diabetes Patients

NCT05788341 | Recruiting

• 1 other identifier: RMC009523ctil
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

We aim at establishing a research program that will offer screening for the presence of Islet Autoantibodies (IA) in relatives of people with Type 1 Diabetes (T1D). Relatives of people with diabetes, children, and adults from our clinic and all over Israel will be offered to participate in the study. The presence of IA will be evaluated using the Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods.. When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology and by a radio binding assay (RBA). People positive for one or more antibodies (stage 1 or 2 T1D) will be referred to attend an educational program at our center. This program will include diabetes education emphasizing DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. After the educational visit, people at risk of developing diabetes will be referred to further follow-up and evaluation under routine medical care at our center.

Conditions

Type 1 Diabetes

Keywords

Stage 1 diabetes; stage 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Positive Islet Autoantibodies

  Screening visit

Eligibility Criteria

• Age: 2 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

First degree relatives of people with TID

You may qualify if:

• First degree family member (sibling or parent) of a known T1D patient
• Age 2-45 years
• Signing an informed consent

You may not qualify if:

• Known diabetes of any kind (type 2, MODY)
• Have a previous history of being treated with insulin or oral diabetes medications.
• Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)

Sponsors & Collaborators

• Rabin Medical Center: lead
• Provention Bio, Inc.: collaborator

Study Sites (1)

Schneider Children Medical Center of Israel

Petah Tikva, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Alona Hamou, Msc

CONTACT

972-545-950277; alonah@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 28, 2023
• Study Start: May 30, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

IL (1)