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

NCT ID: NCT03865914

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-30

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 2 diabetic nephropathy

The cohort will be followed for at least 10 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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Fourth Medical Center of PLA General Hospital

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Third Medical Center of PLA General Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role collaborator

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiangmei Chen

Professor,Chief physician,Academician of Chinese Academy of Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangmei Chen, MD.&Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangmei Chen, MD.&Ph.D

Role: CONTACT

+86 010 66935462

Zheyi Dong, MD.&Ph.D

Role: CONTACT

+86 010 66935462

Facility Contacts

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Xiangmei Chen, MD.&Ph.D

Role: primary

+86 010 66935462

Qian Wang, MM

Role: backup

+86 010 66935462

References

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Dong Z, Wang X, Pan S, Weng T, Chen X, Jiang S, Li Y, Wang Z, Cao X, Wang Q, Chen P, Jiang L, Cai G, Zhang L, Wang Y, Yang J, He Y, Lin H, Wu J, Tang L, Zhou J, Li S, Li Z, Fu Y, Yu X, Geng Y, Zhang Y, Wang L, Xu M, Chen X. A multimodal transformer system for noninvasive diabetic nephropathy diagnosis via retinal imaging. NPJ Digit Med. 2025 Jan 24;8(1):50. doi: 10.1038/s41746-024-01393-1.

Reference Type DERIVED
PMID: 39856403 (View on PubMed)

Wang Q, Cheng H, Jiang S, Zhang L, Liu X, Chen P, Liu J, Li Y, Liu X, Wang L, Li Z, Cai G, Chen X, Dong Z. The relationship between diabetic retinopathy and diabetic nephropathy in type 2 diabetes. Front Endocrinol (Lausanne). 2024 Jan 26;15:1292412. doi: 10.3389/fendo.2024.1292412. eCollection 2024.

Reference Type DERIVED
PMID: 38344659 (View on PubMed)

Zhang W, Liu X, Dong Z, Wang Q, Pei Z, Chen Y, Zheng Y, Wang Y, Chen P, Feng Z, Sun X, Cai G, Chen X. New Diagnostic Model for the Differentiation of Diabetic Nephropathy From Non-Diabetic Nephropathy in Chinese Patients. Front Endocrinol (Lausanne). 2022 Jun 30;13:913021. doi: 10.3389/fendo.2022.913021. eCollection 2022.

Reference Type DERIVED
PMID: 35846333 (View on PubMed)

Qu YL, Dong ZY, Cheng HM, Liu Q, Wang Q, Yang HT, Mao YH, Li JJ, Liu HF, Geng YQ, Huang W, Liu WH, Xie HD, Peng F, Li S, Jiang SS, Li WZ, Duan SW, Feng Z, Zhang WG, Liu YN, Tian JZ, Chen XM. Evaluation of Renal Impairment in Patients with Diabetic Kidney Disease by Integrated Chinese and Western Medicine. Chin J Integr Med. 2023 Apr;29(4):308-315. doi: 10.1007/s11655-022-3520-0. Epub 2022 Jun 9.

Reference Type DERIVED
PMID: 35679002 (View on PubMed)

Other Identifiers

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S2017-133-01

Identifier Type: -

Identifier Source: org_study_id

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