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Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy

Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03865914
Enrollment
2000
Registered
2019-03-07
Start date
2017-11-30
Completion date
2030-12-31
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Kidney Disease

Keywords

Diabetic kidney disease (DKD), Diabetic nephropathy(DN), non-diabetic renal diseases( NDRD), Clinical-pathological correlations, differential diagnosis

Brief summary

With the rapid increase of diabetic nephropathy worldwide, type 2 diabetes mellitus(DM) is the leading cause of end-stage renal disease(ESRD). Pathological types of diabetic kidney disease(DKD) could be mainly divided into diabetic nephropathy(DN)and non-diabetic renal diseases(NDRD). There are no accurate renal biopsy indications and standardized operation procedures for type 2 diabetic nephropathy. The clinical stages of type 2 diabetic nephropathy still referred to the Mogensen stage of type 1 diabetic nephropathy. Thus, our study aim to clarify the differences in clinical phenotype between type 2 DN and type 2 NDRD, analysis the correlation between clinical and pathological features, and offer the criteria for clinical staging and prognosis.

Interventions

None listed

Sponsors

Beijing Municipal Science & Technology Commission
CollaboratorOTHER
China-Japan Friendship Hospital
CollaboratorOTHER
Beijing Friendship Hospital
CollaboratorOTHER
Beijing Hospital
CollaboratorOTHER_GOV
Fourth Medical Center of PLA General Hospital
CollaboratorOTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
CollaboratorOTHER
Third Medical Center of PLA General Hospital
CollaboratorUNKNOWN
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
CollaboratorOTHER
The First Affiliated Hospital of Dalian Medical University
CollaboratorOTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
CollaboratorOTHER
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
CollaboratorOTHER
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
CollaboratorOTHER
Dongzhimen Hospital, Beijing
CollaboratorOTHER
Shanghai University of Traditional Chinese Medicine
CollaboratorOTHER
Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age≥18, male or female * Clinical diagnosed as type 2 diabetes mellitus * The presence of renal impairment including: microalbuminuria or overt proteinuria or renal insufficiency * The renal biopsy was performed with complete renal pathological diagnosis * Obtaining the signed informed consent from patients

Exclusion criteria

* The history of the disease was not complete * Clinical diagnosed as other secondary renal diseases * Patients with hereditary kidney disease * Autoimmune diseases * Patients with malignant tumor were expected to survive less than 6 months * Pregnancy and lactation

Design outcomes

Primary

MeasureTime frameDescription
change in eGFR and urine protein from baseline24monthseGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.

Countries

China

Contacts

Primary ContactXiangmei Chen, MD.&Ph.D
xmchen301@126.com+86 010 66935462
Backup ContactZheyi Dong, MD.&Ph.D
shengdai26@163.com+86 010 66935462

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026