NCT05888909

Brief Summary

Diabetes nephropathy (DN) is one of the most serious microvascular complications of diabetes, and also an important cause of death and disability of diabetes patients. There is no specific clinical staging of type 2 diabetes nephropathy at home and abroad, and there is no comprehensive study to comprehensively describe the occurrence and development of type 2 diabetes nephropathy through sensitive biomarkers, microvascular disease imaging and functional detection, digital markers and other multi-dimensional diagnosis and evaluation methods. Therefore, our research aims to establish a long-term follow-up queue for the whole cycle of diabetes nephropathy, develop multi-dimensional diagnostic and progress digital markers for diabetes nephropathy, develop a multimodal non-invasive diagnostic model and a new clinical staging/typing, and create a multi-dimensional accurate diagnosis and treatment system for type 2 diabetes nephropathy combining traditional Chinese and western medicine.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Aug 2022Dec 2026

Study Start

First participant enrolled

August 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

4.3 years

First QC Date

May 25, 2023

Last Update Submit

May 25, 2023

Conditions

Diabetic Nephropathy Type 2Diabetic Kidney DiseaseType 2 Diabetes

Keywords

Diabetic Nephropathy Type 2Diabetic Kidney DiseaseType 2 DiabetesDiagnosisTreatment

Outcome Measures

Primary Outcomes (1)

  • change in estimated glomerular filtration rate (eGFR) from baseline

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

    24months

Study Arms (1)

Type 2 diabetic nephropathy

The cohort will be divided into 2 or 3 groups according the pathological results of patients,and at least 3 groups according to clinical features such as renal function and proteinuria.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Type 2 diabetes and type 2 diabetes patients with CKD

You may qualify if:

  • Age ≥ 18 years old, regardless of gender; Type 2 diabetes; Having a complete medical history and clinical data; If the patients with type 2 diabetes combined with CKD underwent renal biopsy, the pathological diagnosis should be clear; Patients voluntarily signs an informed consent form.

You may not qualify if:

  • Incomplete medical history or clinical data; Patients with hereditary kidney disease; Combined urinary tract infection; Merge autoimmune system diseases; Patients with malignant tumor were expected to survive less than 6 months; Pregnancy and lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

Related Publications (1)

  • Wang Q, Dong Z, Zhang W, Zheng Y, Lyu Q, Zhang R, Huang H, Liu F, Wang Y, Zhang L, Cao X, Wu J, Zhou J, Cai G, Chen X. COVID-19 epidemic investigation study of a follow-up cohort of patients with diabetic kidney disease. Front Cell Infect Microbiol. 2024 Aug 20;14:1388260. doi: 10.3389/fcimb.2024.1388260. eCollection 2024.

    PMID: 39228893DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, kidney tissue

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes Mellitus, Type 2Disease

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Zheyi Dong, MD

CONTACT

+86 010 66935462shengdai26@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,Chief physician,Academician of Chinese Academy of Engineering

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 5, 2023

Study Start

August 1, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 5, 2023

Record last verified: 2023-05

Locations

CN(1)