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Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

ConditionAutoimmune Thyroid Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorNanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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 design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

834 Participants
are divided into 1 treatment group
Group A: AITD patients (observational cohort)1 intervention

Trial outcomes

Primary outcomes

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).

Time frame
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.

Time frame
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

Time frame
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)

Time frame
Baseline

Secondary outcomes

1

β-cell Function in AITD Patients With Islet Autoantibody Positivity

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.

Time frame
Enrollment within 8-12 weeks
2

Glycemic Metabolic Characteristics of AITD Patients With Islet Autoantibody Positivity

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.

Time frame
Enrollment within 8-12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Medical University

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

Source ClinicalTrials.gov

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