Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorNanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

Voluntary participation and signed informed consent

Age 18-60 years

Diagnosed with autoimmune thyroid disease, with positivity for at least one autoantibody: TPOAb, TgAb, TRAb, or TSI

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Islet autoantibodies tested

Treatment groups

834 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Nanjing Medical University

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution