Precision Medicine of Diabetes Program in China

Recruiting

• Conditions: Diabetes

• Registration Number: NCT06320600
• Lead Sponsor: Second Xiangya Hospital of Central South University

Brief Summary

The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. The patient population is large and heterogeneous, and precise diagnosis and treatment of diabetes patients have been a focus of attention. The objective of this study is to clarify the current status of precision classification and diagnosis of diabetes patients through retrospective and prospective cohort studies, and to establish a model for precision classification and diagnosis of diabetes, improving the accuracy of diabetes classification and diagnosis; based on big data of precision medicine for diabetes patients and follow-up cohorts, to establish precise diagnostic, therapeutic, and predictive methods for diabetes; and through multi-omics data analysis, to explore the potential pathogenesis of diabetes, explaining the heterogeneity of patients, and guiding individualized treatment for patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2024-02-22
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120000

Inclusion Criteria

• Patients diagnosed with diabetes according to WHO 1999 criteria

Exclusion Criteria

• with duration more than 1 year; Diabetes has not been diagnosed by WHO standards in 1999; Absence of medical history data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The currency analysis of diabetes classification	July 1st 2023 to December 31th 2023	To assess the accuracy rate of diabetes classification diagnoses according to "Classification of diabetes mellitus in China: an expert consensus statement" and explore variations across centers in different regions and hospital levels.

Secondary Outcome Measures

Name	Time	Method
To establish a model for predicting diabetic neuropathy	January 1st 2024 to December 31th 2028	To establish a model for diabetic neuropathy prediction, and calculate the sensitivity and specificity of the model were by comparing with the outcome of patients.
To establish a model for predicting diabetic retinopathy	January 1st 2024 to December 31th 2028	To establish a model for diabetic retinopathy prediction, and calculate the sensitivity and specificity of the model were by comparing with the retinopathy outcome of patients.
To establish a model for predicting diabetic kidney disease	January 1st 2024 to December 31th 2028	To establish a model for diabetic kidney disease (DKD) prediction, and calculate the sensitivity and specificity of the model were by comparing with the DKD outcome of patients.

Trial Locations

Locations (1)

the Second Xiangya Hospital; 🇨🇳 Changsha, Hunan, China