Establishment of Screening Pathway for High-Risk Population of Type 1 Diabetes
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
Eligibility
Primary outcome measure(s)
- Changes in HbA1c in patients with type 1 diabetes — From enrollment to the end of the study at 1,2,3,4 years
Changes in HbA1c in patients with type 1 diabetes at baseline and at 1, 2, 3, and 4 years of follow-up - Ther differences in Albumin-to-Creatinine Ratio between type 1 diabetic patients and first-degree relatives and healthy control — From enrollment to the end of the study at 1,2,3,4 years
Albumin-to-Creatinine Ratio will be test in all of the participants - Ther differences in Genotype polymorphisms between type 1 diabetic patients and first-degree relatives and healthy control — From enrollment to the end of the study at 1,2,3,4 years
Blood monitoring to assess genetic polymorphisms in all of the participants - To establish screening and management paths for high-risk groups of type 1 diabetes patients — up to 4 years
Establish an identification and screening system for high-risk groups of type 1 diabetes, as well as a standardized management pathway for these high-risk groups.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07468474 on ClinicalTrials.gov ↗ ← All trials in China