Autoimmune Thyroid Disease Patients Identification and Assessment of Pancreatic Islet Autoimmune Risk
Study to Assess Risk of Pancreatic Islet Autoimmunity in AITD Patients
Plain English Summary
Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD is a Not Applicable clinical trial sponsored by Nanjing Medical University studying Autoimmune Thyroid Disease. This study checks if patients with autoimmune thyroid disease (AITD) might develop islet autoimmunity, which can lead to diabetes. It’s for adults aged 18-60 who have AITD and have at least one thyroid autoantibody. Participants will have blood tests and answer questions about their health and lifestyle. Some may need more tests later. There are other ways to check for diabetes, like regular blood tests and monitoring thyroid function. The trial aims to enroll 834 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18-60, have AITD, and have at least one thyroid autoantibody. You can’t join if you have diabetes, severe health issues, or are taking certain medicines. You must be able to give informed consent and have no severe cardiac, hepatic, or renal dysfunction. Pregnant women or those who are lactating are also excluded. This trial is studying Autoimmune Thyroid Disease, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures will help doctors understand the genetic and clinical factors associated with islet autoantibody positivity, which can guide early intervention and prevention strategies. The specific primary outcome measures are: Genetic Risk Score (GRS) Characteristics in AITD Patients With Islet Autoantibody Positivity (Baseline); HLA Genetic Characteristics of AITD Participants with Islet Autoantibody Positivity (Enrollment within 8-12 weeks); Association Analysis Between Islet Autoantibody Positivity and Clinical/Demographic Risk Factors in AITD Participants (Baseline); Antibody titers in IAb-positive participants: (Baseline); Positivity rate of islet autoantibodies in AITD patients. (Baseline). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important as it aims to identify early signs of islet autoimmunity, which can help in the early detection and management of diabetes in AITD patients. This research targets Autoimmune Thyroid Disease, where improved treatment options are needed.
Investor Insight
The market for early detection and prevention of diabetes is large, and this trial could fill a significant gap by providing a risk assessment model for AITD patients. The large enrollment target of 834 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you have any thyroid autoantibodies and if you are eligible for the study. You will need to provide a blood sample and answer questions about your health and lifestyle. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 834 participants
Interventions
- 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 I
Primary Outcomes
- Genetic Risk Score (GRS) Characteristics in AITD Patients With Islet Autoantibody Positivity (Baseline)
- HLA Genetic Characteristics of AITD Participants with Islet Autoantibody Positivity (Enrollment within 8-12 weeks)
- Association Analysis Between Islet Autoantibody Positivity and Clinical/Demographic Risk Factors in AITD Participants (Baseline)
- Antibody titers in IAb-positive participants: (Baseline)
- Positivity rate of islet autoantibodies in AITD patients. (Baseline)
Secondary Outcomes
- 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)
Full Eligibility Criteria
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
Frequently Asked Questions
What is clinical trial NCT07494474?
NCT07494474 is a Not Applicable OBSERVATIONAL study titled "Risk Assessment of Pancreatic Islet Autoimmunity in Patients With AITD." It is currently not yet recruiting and is sponsored by Nanjing Medical University. The trial targets enrollment of 834 participants.
What conditions does NCT07494474 study?
This trial investigates treatments for Autoimmune Thyroid Disease. The primary condition under study is Autoimmune Thyroid Disease.
What treatments are being tested in NCT07494474?
The interventions being studied include: 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 I
What does Not Applicable mean for NCT07494474?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07494474?
This trial is currently "Not Yet Recruiting." It started on 2026-08-31. The estimated completion date is 2028-04-30.
Who is sponsoring NCT07494474?
NCT07494474 is sponsored by Nanjing Medical University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07494474?
The trial aims to enroll 834 participants. The trial has not yet started recruiting.
How is NCT07494474 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07494474?
The primary outcome measures are: Genetic Risk Score (GRS) Characteristics in AITD Patients With Islet Autoantibody Positivity (Baseline); HLA Genetic Characteristics of AITD Participants with Islet Autoantibody Positivity (Enrollment within 8-12 weeks); Association Analysis Between Islet Autoantibody Positivity and Clinical/Demographic Risk Factors in AITD Participants (Baseline); Antibody titers in IAb-positive participants: (Baseline); Positivity rate of islet autoantibodies in AITD patients. (Baseline). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07494474?
The official record for NCT07494474 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07494474. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07494474 testing in simple terms?
This study checks if patients with autoimmune thyroid disease (AITD) might develop islet autoimmunity, which can lead to diabetes. It’s for adults aged 18-60 who have AITD and have at least one thyroid autoantibody.
Why is this trial significant?
This trial is important as it aims to identify early signs of islet autoimmunity, which can help in the early detection and management of diabetes in AITD patients.
What are the potential risks of participating in NCT07494474?
There are no specific side effects mentioned, but as with any blood test, there is a small risk of bruising or infection at the site of the needle. The study involves genetic testing, which may raise privacy concerns. Make sure you understand the implications. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07494474?
Ask your doctor if you have any thyroid autoantibodies and if you are eligible for the study. You will need to provide a blood sample and answer questions about your health and lifestyle. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07494474 signal from an investment perspective?
The market for early detection and prevention of diabetes is large, and this trial could fill a significant gap by providing a risk assessment model for AITD patients. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have blood tests and answer questions about their health and lifestyle. Some may need more tests later. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.