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NCT07494474Not yet recruiting

Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
834 (estimated)
First submitted
20 Mar 2026
Start date
Aug 2026
Primary completion date
Nov 2027
Lead sponsor
Nanjing Medical University
NCT number
NCT07494474

What you commit to

  • Study type: Observational
  • Planned participants: 834
  • From Aug 2026 to the primary completion date, Nov 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.