Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

March 20, 2026 updated by: Yong Gu, Nanjing Medical University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

834

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion criteria：

  1. Voluntary participation and signed informed consent
  2. Age 18-60 years
  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AITD patients (observational cohort)
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 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic Risk Score (GRS) Characteristics in AITD Patients With Islet Autoantibody Positivity
Time Frame: Baseline
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).
Baseline
HLA Genetic Characteristics of AITD Participants with Islet Autoantibody Positivity
Time Frame: Enrollment within 8-12 weeks
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.
Enrollment within 8-12 weeks
Association Analysis Between Islet Autoantibody Positivity and Clinical/Demographic Risk Factors in AITD Participants
Time Frame: Baseline
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
Baseline
Antibody titers in IAb-positive participants:
Time Frame: Baseline
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)
Baseline
Positivity rate of islet autoantibodies in AITD patients.
Time Frame: Baseline
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)
Baseline
Distribution of islet autoantibody profiles.
Time Frame: Baseline
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)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
β-cell Function in AITD Patients With Islet Autoantibody Positivity
Time Frame: Enrollment within 8-12 weeks
Describe and analyze fasting C-peptide levels and/or the area under the C-peptide curve (AUC-C-peptide) derived from the OGTT among participants with islet autoantibody positivity.
Enrollment within 8-12 weeks
Glycemic Metabolic Characteristics of AITD Patients With Islet Autoantibody Positivity
Time Frame: Enrollment within 8-12 weeks
Based on OGTT and WHO diagnostic criteria, describe and analyze the proportions of participants with normal glucose regulation and abnormal glucose metabolism (including impaired fasting glucose and impaired glucose tolerance). Describe the glycated hemoglobin (HbA1c) levels of individuals with islet autoantibody positivity.
Enrollment within 8-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-SR-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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