NCT07468474

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 340 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Accepted

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.

Detailed description

1. For patients with type 1 diabetes, the intervention includes two aspects: Firstly, at the time of subject enrollment, a 12-hour structured course is conducted, covering various aspects such as diabetes diet, exercise, blood sugar monitoring, insulin injection, complication prevention, and psychological adjustment. Secondly, regular outpatient follow-ups are carried out, with a frequency of once every 3 months. The follow-up content includes routine outpatient visit-related items, such as blood sugar, islet function, liver and kidney function, blood lipid, etc., as well as screening for diabetes complications. Follow-ups are conducted regularly based on the time of type 1 diabetes diagnosis. 2. For the first-degree relatives of patients with type 1 diabetes: At the time of subject enrollment, blood samples are taken for genetic polymorphism testing, islet-related autoantibody determination, blood sugar, glycosylated hemoglobin, and islet function assessment; urine samples are collected for urine proteomics determination. Stool samples are collected for stool intestinal flora determination. Subsequently, follow-ups are conducted once a year, with blood sampling and collection of urine and stool samples for the same items as in the baseline follow-up. 3. For healthy control populations, no follow-up arrangements are made. At the time of subject enrollment, blood samples are taken for genetic polymorphism testing, islet-related autoantibody determination, blood sugar, glycosylated hemoglobin, and islet function assessment; urine samples are collected for urine proteomics determination. Stool samples are collected for stool intestinal flora determination.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: China