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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05888909
Other study ID # S2022-482-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date December 31, 2026

Study information

Verified date May 2023
Source Chinese PLA General Hospital
Contact Zheyi Dong, MD
Phone +86 010 66935462
Email shengdai26@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diabetes nephropathy (DN) is one of the most serious microvascular complications of diabetes, and also an important cause of death and disability of diabetes patients. There is no specific clinical staging of type 2 diabetes nephropathy at home and abroad, and there is no comprehensive study to comprehensively describe the occurrence and development of type 2 diabetes nephropathy through sensitive biomarkers, microvascular disease imaging and functional detection, digital markers and other multi-dimensional diagnosis and evaluation methods. Therefore, our research aims to establish a long-term follow-up queue for the whole cycle of diabetes nephropathy, develop multi-dimensional diagnostic and progress digital markers for diabetes nephropathy, develop a multimodal non-invasive diagnostic model and a new clinical staging/typing, and create a multi-dimensional accurate diagnosis and treatment system for type 2 diabetes nephropathy combining traditional Chinese and western medicine.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2026
Est. primary completion date November 1, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Age = 18 years old, regardless of gender; Type 2 diabetes; Having a complete medical history and clinical data; If the patients with type 2 diabetes combined with CKD underwent renal biopsy, the pathological diagnosis should be clear; Patients voluntarily signs an informed consent form. Exclusion criteria: Incomplete medical history or clinical data; Patients with hereditary kidney disease; Combined urinary tract infection; Merge autoimmune system diseases; Patients with malignant tumor were expected to survive less than 6 months; Pregnancy and lactation.

Study Design


Locations

Country Name City State
China Chinese PLA General Hospital Beijing

Sponsors (8)

Lead Sponsor Collaborator
Chinese PLA General Hospital Beijing Friendship Hospital, Beijing Hospital, Beijing Municipal Science & Technology Commission, Beijing Tongren Hospital, China-Japan Friendship Hospital, Dongzhimen Hospital, Beijing, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in estimated glomerular filtration rate (eGFR) from baseline eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine. 24months
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