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

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ClinicalTrials.gov Identifier: NCT03865914
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
Beijing Municipal Science & Technology Commission
China-Japan Friendship Hospital
Beijing Friendship Hospital
Beijing Hospital
First Hospitals affiliated to the China PLA General Hospital
Information provided by (Responsible Party):
Xiangmei Chen, Chinese PLA General Hospital

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.

Condition or disease
Diabetic Kidney Disease

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Type 2 diabetic nephropathy
The cohort will be followed for at least two years. The cohort will be divided into 2 groups according the pathological results of patients,and at least 3 groups according to clinical features such as renal function and proteinuria.



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood, urine, kidney tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The aim of this study is 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865914


Contacts
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Contact: Xiangmei Chen, MD.&Ph.D +86 010 66935462 xmchen301@126.com
Contact: Zheyi Dong, MD.&Ph.D +86 010 66935462 shengdai26@163.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Xiangmei Chen, MD.&Ph.D    +86 010 66935462    xmchen301@126.com   
Contact: Qian Wang, MM    +86 010 66935462    794317255@qq.com   
Principal Investigator: Xiangmei Chen, MD.&Ph.D         
Sub-Investigator: Zheyi Dong, MD.&Ph.D         
Sponsors and Collaborators
Chinese PLA General Hospital
Beijing Municipal Science & Technology Commission
China-Japan Friendship Hospital
Beijing Friendship Hospital
Beijing Hospital
First Hospitals affiliated to the China PLA General Hospital
Investigators
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Principal Investigator: Xiangmei Chen, MD.&Ph.D Chinese PLA General Hospital

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Responsible Party: Xiangmei Chen, Professor,Chief physician,Academician of Chinese Academy of Engineering, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03865914     History of Changes
Other Study ID Numbers: S2017-133-01
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The test has not been completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiangmei Chen, Chinese PLA General Hospital:
Diabetic kidney disease (DKD)
Diabetic nephropathy(DN)
non-diabetic renal diseases( NDRD)
Clinical-pathological correlations
differential diagnosis

Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases