NCT07494474

Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

Autoimmune Thyroid Disease Patients Identification and Assessment of Pancreatic Islet Autoimmune Risk

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 834 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the risk of islet autoimmunity in patients with autoimmune thyroid disease (AITD), describe related clinical and laboratory characteristics, and explore the development of a risk assessment model based on clinical, laboratory, and genetic markers. Adults aged 18-60 years with confirmed AITD will undergo baseline assessment including demographic data, anthropometric measures, lifestyle factors, medical history, thyroid-related clinical information, thyroid function, and thyroid antibody testing. A baseline blood sample will be collected for measurement of islet autoantibodies (GADA, IA-2A, ZnT8A, and IAA). Participants with positive islet autoantibodies will undergo further evaluation of glucose metabolism and beta-cell function, including HbA1c, OGTT, insulin, and C-peptide testing. Genome-wide genetic data will be used to construct a type 1 diabetes-related genetic risk score, and additional HLA genotyping may be performed in autoantibody-positive participants. The study will assess the prevalence and profile of islet autoantibodies in AITD and identify clinical, laboratory, and genetic factors associated with islet autoantibody positivity.

Conditions

• Autoimmune Thyroid Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Islet autoantibodies tested	This is an observational study. Eligible participants are patients aged 18-60 years with autoimmune thyroid disease (AITD), including Hashimoto's thyroiditis and Graves' disease, diagnosed by an endocrinology specialist. At baseline, demographic information, physical measurements, lifestyle factors, AITD-related clinical data, thyroid function, and thyroid autoantibody levels will be collected. Blood samples will also be obtained for measurement of islet autoantibodies (GADA, IA-2A, ZnT8A, and IAA) and their titers. Participants who test positive for islet autoantibodies will, within 2 months, undergo further evaluation including HbA1c testing, OGTT with insulin and C-peptide assessment, and HLA genotyping. A type 1 diabetes-related genetic risk score (GRS) will be constructed for all participants for exploratory analysis. No therapeutic intervention will be administered in this study.

Timeline

• Start date: 2026-08-31
• Primary completion: 2027-11-30
• Completion: 2028-04-30
• First posted: 2026-03-27
• Last updated: 2026-03-27