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

Diabetic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03865914
• Other study ID #: S2017-133-01
• Status: Recruiting
• Start date: November 30, 2017
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2022
• Source: Chinese PLA General Hospital
• Contact: Xiangmei Chen, MD.&Ph.D
• Phone: +86 010 66935462
• Email: xmchen301[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2030
• Est. primary completion date: November 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (15)

Lead Sponsor

Collaborator

Chinese PLA General Hospital

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 University of Chinese Medicine, 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 PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in eGFR and urine protein from baseline	eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.	24months