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

NCT07468474 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 340

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

GENETIC

Gene 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.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Donghui Zhang · Peking University First Hospital

  • Nan Gu · Peking University First Hospital

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2027-07-31
Completion
2028-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07468474 on ClinicalTrials.gov