Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 60 years
• All sexes
• No healthy volunteers
• Adult

Study population: Adults aged 18-60 years with autoimmune thyroid disease (AITD), including Hashimoto's thyroiditis and Graves' disease, diagnosed by an endocrinology specialist, will be enrolled from the inpatient and outpatient clinics of the Department of Endocrinology, thyroid specialty clinics, and screening programs at the First Affiliated Hospital of Nanjing Medical University/Jiangsu Provincial People's Hospital. This observational study focuses on AITD patients without therapeutic intervention and evaluates islet autoimmunity, glucose metabolism, beta-cell function, and genetic risk.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Autoimmune Thyroid Disease Patients Identification and Assessment of Pancreatic Islet Autoimmune Risk

Conditions

Autoimmune Thyroid Disease

Being tested

Islet autoantibodies tested

Keywords

AITD, Islet autoantibodies, type 1 diabetes

Medical subject headings

Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Islet autoantibodies testedDiagnostic test

  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 IAA) and their titers. Participants who test positive for islet autoantibodies will, within 2 months, undergo further evaluation including HbA1c testing, OGTT with insulin and C-peptide assessment, and HLA genotyping. A type 1 diabetes-related genetic risk score (GRS) will be constructed for all participants for exploratory analysis. No therapeutic intervention will be administered in this study.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Genetic Risk Score (GRS) Characteristics in AITD Patients With Islet Autoantibody Positivity

   Describe and analyze the type 1 diabetes-specific composite genetic risk score (GRS) among participants with islet autoantibody positivity. Evaluate the association strength between high genetic risk (e.g., GRS in the upper quartile of the study population) and islet autoantibody positivity, expressed as odds ratios (ORs).

   Measured: Baseline

2. HLA Genetic Characteristics of AITD Participants with Islet Autoantibody Positivity

   Conduct HLA genotyping (e.g., HLA-DR, HLA-DQ) among participants who are positive for islet autoantibodies to describe the distribution of their alleles and haplotypes. Perform exploratory analyses to determine whether specific HLA alleles or haplotypes associated with high risk of type 1 diabetes are present among antibody-positive individuals.

   Measured: Enrollment within 8-12 weeks

3. Association Analysis Between Islet Autoantibody Positivity and Clinical/Demographic Risk Factors in AITD Participants

   Using multivariable regression analysis, identify non-genetic factors independently associated with islet autoantibody positivity and report adjusted odds ratios (aORs) and confidence intervals (CIs). Proposed risk factors include: - Demographics: age, sex, BMI, waist-to-hip ratio, smoking history, alcohol consumption history; - Medical history, personal history, family history: family history of diabetes; history of other autoimmune diseases in first-degree relatives, such as autoimmune thyroid disease, rheumatoid arthritis, systemic lupus erythematosus; presence of other confirmed autoimmun

   Measured: Baseline

4. Antibody titers in IAb-positive participants:

   Standardized immunoassay based on a single blood sample, reference value range for each antibody: GADA (reference value <10 IU/mL); IAA (reference value <1 COI); IA-2A (reference value < 10 IU/mL); ZnT8A (reference value <10 AU/mL)

   Measured: Baseline

5. Positivity rate of islet autoantibodies in AITD patients.

   Standardized immunoassay based on a single blood sample, reference value range for each antibody: GADA (reference value <10 IU/mL); IAA (reference value <1 COI); IA-2A (reference value < 10 IU/mL); ZnT8A (reference value <10 AU/mL)

   Measured: Baseline

6. Distribution of islet autoantibody profiles.

   Standardized immunoassay based on a single blood sample, reference value range for each antibody: GADA (reference value <10 IU/mL); IAA (reference value <1 COI); IA-2A (reference value < 10 IU/mL); ZnT8A (reference value <10 AU/mL)

   Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted27 Mar 2026
2. Study start31 Aug 2026 (estimated)
3. Primary completion30 Nov 2027 (estimated)
4. Study completion30 Apr 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Autoimmune Thyroid DiseaseStudies of the same condition, open and under way.
• More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.