Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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 I

Первичные конечные точки

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

Вторичные конечные точки (2)

• β-cell Function in AITD Patients With Islet Autoantibody Positivity [Срок оценки: Enrollment within 8-12 weeks]
• Glycemic Metabolic Characteristics of AITD Patients With Islet Autoantibody Positivity [Срок оценки: Enrollment within 8-12 weeks]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07494474 · 2026-SR-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗