Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

NCT07494474 | Not Yet Recruiting DMC

• 1 other identifier: 2026-SR-001
• Study Type: observational
• Target: 834
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autoimmune Thyroid Disease

Keywords

AITD; Islet autoantibodies; type 1 diabetes

Outcome Measures

Primary Outcomes (6)

• 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).

  Baseline

• 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.

  Enrollment within 8-12 weeks

• 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

  Baseline

• 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)

  Baseline

• 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)

  Baseline

• 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)

  Baseline

Secondary Outcomes (2)

• β-cell Function in AITD Patients With Islet Autoantibody Positivity

  Enrollment within 8-12 weeks

• Glycemic Metabolic Characteristics of AITD Patients With Islet Autoantibody Positivity

  Enrollment within 8-12 weeks

Study Arms (1)

AITD patients (observational cohort)

Diagnostic Test: Islet autoantibodies tested

Interventions

Islet autoantibodies tested DIAGNOSTIC_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.

AITD patients (observational cohort)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Voluntary participation and signed informed consent
• Age 18-60 years

You may not qualify if:

• : 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, Blood sample, Stool, Urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Yong Gu

CONTACT

+86 02568303017; yong.gu@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03