Multidimensional Accurate Diagnosis and Treatment Technology and Clinical Transformation of Type 2 Diabetes Nephropathy

May 25, 2023 updated by: Xiangmei Chen, Chinese PLA General Hospital
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Type 2 diabetes and type 2 diabetes patients with CKD

Description

Inclusion Criteria:

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.

Exclusion criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in estimated glomerular filtration rate (eGFR) from baseline
Time Frame: 24months
eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.
24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Collaborators

Beijing Friendship Hospital
Xuanwu Hospital, Beijing
Beijing Tongren Hospital
Beijing Municipal Science & Technology Commission
Beijing Hospital
China-Japan Friendship Hospital
Dongzhimen Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2022-482-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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