RecruitingNCT07468474

Establishment of Screening Pathway for High-Risk Population of Type 1 Diabetes

Sponsor

Peking University First Hospital

Enrollment

340 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

Type 1 Diabetes Mellitus

Summary

This study aims to establish a system for identifying and screening high-risk individuals for type 1 diabetes (T1D) and a standardized management pathway for high-risk individuals. It is a prospective cohort study. We plan to enroll 340 eligible subjects, including 40 healthy controls of the same gender and age, 150 T1D patients, and 150 first-degree relatives of T1D patients. The follow-up visit cycle for T1D patients and their first-degree relatives is 4 years. Blood samples will be collected annually for genetic polymorphism testing, pancreatic islet-related autoantibody measurement, blood glucose, hemoglobin A1c, and pancreatic function assessment. Urine samples will be collected for urine proteomics measurement. Fecal samples will be collected for fecal intestinal microbiota measurement. The value of pancreatic islet autoantibody markers in predicting T1D high-risk individuals will be evaluated, and a multi-gene risk score (PRS) prediction model will be established for subtypes of T1D, including acute and chronic T1D. A comprehensive T1D high-risk individual identification and screening system will be established and promoted for application.

Eligibility

Min Age: 4 Years

Plain Language Summary

Simplified for easier understanding

This study is building a screening program to identify people at high risk for Type 1 diabetes — including those already diagnosed, their close relatives, and healthy adults — so that early steps can be taken before diabetes develops or complications occur. **You may be eligible if...** - You have been diagnosed with Type 1 diabetes and are able to attend regular follow-up appointments - OR you are a parent, child, or sibling of someone with Type 1 diabetes and are aged 4 or older - OR you are a healthy adult aged 40 or older with no history of diabetes and normal blood sugar results **You may NOT be eligible if...** - You have a different type of diabetes (not Type 1) - You have serious complications from diabetes such as severe kidney disease, uncontrolled blood pressure, advanced eye disease, or recent stroke or heart attack - You are taking medications that significantly affect blood sugar (like high-dose steroids) - You have a serious infection, cancer, or chronic diarrhea - You have cognitive or mental health conditions that prevent you from following the study requirements - (For healthy adults) You have a first- or second-degree relative with Type 1 diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICGene polymorphic detection

The follow-up visit period of T1D patients and their first-degree relatives was 4 years. Blood samples were collected every year for detection of gene polymorphism, determination of islet related autoantibodies, blood glucose, glycated hemoglobin, and islet function evaluation. Urine samples were collected for urinary proteomic determination. Stool samples were collected for the determination of stool intestinal flora.