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NCT Number: NCT07494474

Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

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.

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Key information

Conditions

Autoimmune Thyroid Disease Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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

  4. 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)

  5. 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)

  6. 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)

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yong Gu

CONTACT

[email protected]

+86 02568303017

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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