Autoimmune Thyroid Disease Patients Identification and Assessment of Pancreatic Islet Autoimmune Risk
Official 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.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 834 participants
Interventions
- 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 I
Primary Outcomes
- Genetic Risk Score (GRS) Characteristics in AITD Patients With Islet Autoantibody Positivity (Baseline)
- HLA Genetic Characteristics of AITD Participants with Islet Autoantibody Positivity (Enrollment within 8-12 weeks)
- Association Analysis Between Islet Autoantibody Positivity and Clinical/Demographic Risk Factors in AITD Participants (Baseline)
- Antibody titers in IAb-positive participants: (Baseline)
- Positivity rate of islet autoantibodies in AITD patients. (Baseline)
Secondary Outcomes
- β-cell Function in AITD Patients With Islet Autoantibody Positivity (Enrollment within 8-12 weeks)
- Glycemic Metabolic Characteristics of AITD Patients With Islet Autoantibody Positivity (Enrollment within 8-12 weeks)
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.