Multidimensional Accurate Diagnosis and Treatment Technology and Clinical Transformation of Type 2 Diabetes Nephropathy

NCT ID: NCT05888909

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Nephropathy Type 2 Diabetic Kidney Disease Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Type 2 diabetic nephropathy

The cohort will be divided into 2 or 3 groups according the pathological results of patients,and at least 3 groups according to clinical features such as renal function and proteinuria.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiangmei Chen

Professor,Chief physician,Academician of Chinese Academy of Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chinese PLA General Hospital

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zheyi Dong, MD

Role: CONTACT

+86 010 66935462

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiangmei Chen, MD.&Ph.D

Role: primary

+86 010 66935462

References

Explore related publications, articles, or registry entries linked to this study.

Wang Q, Dong Z, Zhang W, Zheng Y, Lyu Q, Zhang R, Huang H, Liu F, Wang Y, Zhang L, Cao X, Wu J, Zhou J, Cai G, Chen X. COVID-19 epidemic investigation study of a follow-up cohort of patients with diabetic kidney disease. Front Cell Infect Microbiol. 2024 Aug 20;14:1388260. doi: 10.3389/fcimb.2024.1388260. eCollection 2024.

Reference Type DERIVED
PMID: 39228893 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S2022-482-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.