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

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.

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Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

change in eGFR and urine protein from baseline

Time frame: 24months

eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.

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Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

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

Registry information

Important dates

Study start: 2017
Primary completion: 2027
Study completion: 2030
First posted: Mar 7, 2019
Registry last updated: Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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