The Influence of the Thickening of Bowman's Capsule on the Clinical Prognosis of Patients With Diabetic Kidney Disease

NCT06049550 | Unknown

• 1 other identifier: IIT-2023-0174
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diabetic kidney disease (DKD) is the leading cause for renal replacement therapy in developed country. DKD is also the primary cause of ESKD among middle-aged and elderly people in China. Renal pathological markers have been proved to have clinical and prognostic value in both non diabetic and diabetic kidney diseases. To discriminate lesions by various degrees of severity, the Working Group of the Renal Pathology Society (RPS) developed a pathologic classification for DKD in 2010. The classification is based on glomerular lesions, with a separate evaluation for interstitial and vascular lesions. In a decade, there were several new characteristics common to DKD, such as the presence of mesangiolysis, glomerular hyalinosis, segmental sclerosis and extracapillary hypercellularity, which have been noted in patients with diabetes and may have prognostic importance. But it is still unclear whether thickening of Bowman's capsule predicts the progression of DKD.

Conditions

Diabetic Kidney Disease; Extracellular Matrix Alteration

Keywords

Diabetic Kidney Disease; extracellular matrix; parietal epithelial cells

Outcome Measures

Primary Outcomes (1)

• renal failure

  estimated glomerular filtration rate（eGFR）\<15ml/min/1.73m2, renal replacement treatment or death caused by renal disease

  From the diagnosis of diabetes kidney disease by renal biopsy to December 31, 2022

Study Arms (2)

mild thicknening of Bowman's Capsule

Other: no intervention

severe thickening of Bowman's Capsule

Other: no intervention

Interventions

no intervention OTHER

no intervention

mild thicknening of Bowman's Capsule; severe thickening of Bowman's Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosised as diabetic kidney disease by renal biopsy from January 1, 2017 to December 31, 2021 in Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, the First Affiliated Hospital of China Medical University, Shanghai Sixth People's Hospital and Shanghai General Hospital.

You may qualify if:

• \) Age ≥ 18 years old, male or female 2) Patients diagnosed as diabetes kidney disease by renal biopsy

You may not qualify if:

• \) Patients combined with non diabetes kidney disease; 2) Patients with kidney transplant failure; 3) Patients undergoing zero point puncture for kidney transplantation; 4) less than 5 glomeruli in the renal puncture sample.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Jiayue Lu

CONTACT

86-21-34506332; royalkeane@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 22, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 31, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09