Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Islet autoantibodies tested.
- Who it may be relevant to
- Registry conditions: Autoimmune Thyroid Disease. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Autoimmune Thyroid Disease Patients Identification and Assessment of Pancreatic Islet Autoimmune Risk
Overview
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.
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 outcome measures
- Genetic Risk Score (GRS) Characteristics in AITD Patients With Islet Autoantibody Positivity [Time frame: Baseline]
- HLA Genetic Characteristics of AITD Participants with Islet Autoantibody Positivity [Time frame: Enrollment within 8-12 weeks]
- Association Analysis Between Islet Autoantibody Positivity and Clinical/Demographic Risk Factors in AITD Participants [Time frame: Baseline]
- Antibody titers in IAb-positive participants: [Time frame: Baseline]
- Positivity rate of islet autoantibodies in AITD patients. [Time frame: Baseline]
- Distribution of islet autoantibody profiles. [Time frame: Baseline]
Secondary outcome measures (2)
- β-cell Function in AITD Patients With Islet Autoantibody Positivity [Time frame: Enrollment within 8-12 weeks]
- Glycemic Metabolic Characteristics of AITD Patients With Islet Autoantibody Positivity [Time frame: Enrollment within 8-12 weeks]
Eligibility criteria
Inclusion criteria：
- 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 Exclusion criteria：
1: Previously diagnosed diabetes mellitus or current diabetes treatment 2: Conditions severely affecting glucose metabolism (e.g., Cushing's syndrome, acromegaly) 3: Use of immunosuppressants or high-dose glucocorticoids within the past 3 months 4: Pregnancy or lactation 5: Severe cardiac, hepatic, or renal dysfunction, or any condition unsuitable for participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07494474 · 2026-SR-001