The Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy

NCT06843304 | Recruiting DMC

• 1 other identifier: S2023-509-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic nephropathy is one of the most severe microvascular complications of diabetes and a major cause of premature death and disability. It has become a leading cause of end-stage renal failure both in China and worldwide, consuming substantial medical resources. The establishment of a comprehensive regulatory system for the development and progression of diabetic nephropathy is a critical need for effective prevention and control. However, there is a lack of representative cohorts covering the entire disease cycle of diabetic nephropathy both domestically and internationally, creating technical bottlenecks in comprehensively describing its developmental patterns. This project aims to expand and integrate existing large-sample natural population cohorts and prospective follow-up cohorts covering the entire disease cycle of diabetes and diabetic nephropathy. It will construct a panoramic life database to identify risk factors, clinical phenotypes, and multimodal biomarkers at different disease stages. By integrating multi-organ interactions (e.g., kidney, eye), the project will establish novel imaging and functional assessment technologies for microvascular complications. Utilizing artificial intelligence to process multimodal medical data, it will build and validate risk prediction models and evaluation systems for the entire disease cycle of diabetic nephropathy. The project will develop effective intelligent prevention and treatment strategies for diabetic nephropathy, promote the adoption of new technologies, and establish a medical quality control system to provide services for medical institutions. Ultimately, it aims to improve and sustain medical quality, reducing the incidence of end-stage renal disease.

Conditions

Diabetic Nephropathy; T2DM

Outcome Measures

Primary Outcomes (1)

• The incidence of complex renal endpoints

  The incidence of complex renal endpoints includes eGFR decreased progressively by more than 30% from baseline, ESRD and all-cause death.

  3 years

Study Arms (1)

Patients with type 2 diabetes mellitus and type 2 diabetes mellitus with CKD

Based on the national multi-center diabetic nephropathy cohort built since 2017, and continues to establish prospective diabetes nephropathy whole life cycle cohort. Individuals with type 2 diabetes will be followed up until renal dysfunction occurs and continue to be followed up until the occurrence of renal endpoints. Individuals with diabetic nephropathy of type 2 diabetes will be followed up until the occurrence of renal endpoints.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with type 2 diabetes mellitus and type 2 diabetes mellitus with CKD

You may qualify if:

• Age ≥18 years old, gender is not limited
• Diagnosed with type 2 diabetes
• A history of type 2 diabetes for more than 5 years
• Negative proteinuria
• Creatinine is normal
• Good compliance, voluntarily sign informed consent

You may not qualify if:

• Incomplete medical records
• Lack of fundus microvascular examination or new imaging technology examination results data
• Combined with autoimmune diseases and tumors
• Type 2 diabetes patients undergoing renal biopsy
• Age ≥18 years old, gender is not limited
• Diagnosed with type 2 diabetes
• Kidney damage (microalbuminuria or dominant albuminuria or renal insufficiency)
• Have undergone renal puncture biopsy and have complete renal pathological diagnosis data
• Sign informed consent voluntarily
• Gestational diabetes mellitus, special type diabetes mellitus
• Patients with hereditary kidney disease
• Combined with autoimmune diseases
• Diabetic nephropathy The indicators in the comprehensive assessment model of the risk of renal progression could not be obtained
• There were pregnancy plans in the study period

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, kidney tissue

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Zheyi Dong, MD

CONTACT

+86 13810261592; shengdai26@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician/Principal Investigator/ Clinical Professor/Director

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 24, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

CN (1)