Type 1 Diabetes (T1D) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 4
Healthy Volunteers: t
View:

⁃ Meet the WHO's diabetes diagnostic criteria, diagnosed as type 1 diabetes; ② Able and willing to participate in 12 hours of structured education training;

‣ Able and willing to undergo regular outpatient follow-up;

∙ Volunteer to participate in the study and sign informed consent.

• First-degree relatives of patients with type 1 diabetes (including parents, children, siblings);

⁃ Age ≥4 years old; ③ Able and willing to undergo regular outpatient follow-up; ④ Volunteer to participate in the study and sign informed consent.

• Age ≥40 years old;

⁃ No history of diabetes; ③ Fasting blood glucose \< 6.1mmol/L, 2-hour glucose load blood glucose \< 7.8mmol /L, glycosylated hemoglobin \< 5.7%; ④ Volunteer to participate in the study and sign informed consent.

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Nan Gu
13811135033@163.com
+8613811135033
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2028-07
Participants
Target number of participants: 340
Related Therapeutic Areas
Sponsors
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov