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NCT07494474

Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

Not Yet Recruiting · Not specified · Nanjing Medical University · registry updated 2026-03-27

Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.

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.

Inclusion

  • 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

  • Exclusion criteria:
  • : 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

Open NCT07494474 on ClinicalTrials.govAll conditions