Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04931537
Other study ID # zhengchao-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date December 31, 2028

Study information

Verified date June 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Zheng Chao, MD, PhD
Phone 8615057585907
Email wallbb_1022@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Diabetic nephropathy (DN) is one of the major microvascular complications associated with diabetic patients, and also the major global cause of chronic kidney disease and end-stage renal disease (ESRD). Albuminuria and estimated glomerular filtration rate (eGFR) are currently recognized clinical indicators for early diagnosis of DN, however, the sensitivity and specificity are unsatisfactory. The early identification and treatment of DKD are conducive to lowering the risk of kidney damage by as much as 50%. Therefore, it is particularly critical to find new biomarkers to reflect the potential DKD lesions in the clinical silent period earlier and more accurately. Therefore, this study intends to analyze the differentially expressed lipids in early DKD, T2DM and healthy adults by mass spectrometry, and verify the related results by larger samples, so as to screen out early markers of DKD and achieve the ultimate goal of clinical application.


Description:

The present study was a scientific research project concurrently conducted by clinical and laboratory. In term of clinical research, the basic personal data, medical history, physical examination and auxiliary examination results of subjects were mainly recorded. Whereas in term of basic research, the serum, plasma and urine samples of patients were collected for serological and metabonomics research to find new biomarkers. First, we recruited the patients who met the inclusion criteria. The patients' serum, plasma and urine were collected at baseline after obtaining informed patient consent. Simultaneously, the basic information, anthropometric indicators (including height, weight, waist circumference, hip circumference, blood pressure), past history, family history, menstrual history, birth history, medication history, lifestyle of the patients were registered, and the corresponding laboratory examination and auxiliary examination were carried out according to the diagnostic process. All data and data were entered into the database for later analysis. After the initial diagnosis, the patients were enrolled in the current trial. The patients were followed up annually until the last follow-up visit, and the complete follow-up was conducted for at least 5 years. Each follow-up followed the principles of routine clinical diagnosis and treatment. In addition, the patients' serum, plasma and urine samples were collected once a year during follow-up, and a centralized test of glycosylated hemoglobin was performed once a year. In this study, the pathogenesis of type 2 diabetic nephropathy was explored through multi-center standardized clinical follow-up; The potential mechanism and possible biomarkers in patients with early renal diseases of type 2 diabetes was explored through prospective long-term follow-up, so as to find novel therapeutic approaches and suitable population.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2028
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Subjects who have signed informed consent. 2. Subjects were 20-80 years old and of either gender. 3. Subjects showed good compliance, and the follow-up data was available for >5 years. Exclusion Criteria: 1. Meet the 1999 World Health Organization (WHO) diagnostic criteria for T1DM?T2DM; 2. Renal diseases caused by other causes, including primary and secondary; 3. All kinds of acute infections; 4. The expected life expectancy (life expectancy or related diseases) was less than 5 years according to the researcher's judgment. 5. Drug users or drug abusers; 6. Sexually transmitted diseases such as viral hepatitis, AIDS and syphilis, and infectious diseases such as tuberculosis are in an active period; 7. Any situation judged by the researcher that affects enrollment.

Study Design


Locations

Country Name City State
China the Second Affiliated Hospital Zhejiang University Schoolof Medicine Hangzhou

Sponsors (3)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University Lishui Country People's Hospital, Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary Albumin Creatinine Ratio,UACR Urinary Albumin Creatinine Ratio 5years
See also
  Status Clinical Trial Phase
Recruiting NCT03219593 - Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer Phase 2
Active, not recruiting NCT04681040 - Risk Stratification of COVID-19 Using Urine Biomarkers
Recruiting NCT05372172 - Tennessee Alzheimer's Project
Recruiting NCT06096766 - the Correlation Between Ovarian Function and Serum Biomarkers
Completed NCT04103632 - Screening and Diagnosing Exercise-induced Bronchoconstriction in Recreational Young Athletes (12-18 y) N/A
Completed NCT01159730 - Study to Assess the Safety and Efficacy of Multiple Doses of VB-201 on Biomarkers Phase 2
Completed NCT04507724 - The Use of Biochemical Analyzes to Monitor the Development of Wounds
Completed NCT06338111 - Can we Improve Mortality Prediction in Patients With Sepsis in the Emergency Department
Active, not recruiting NCT05027165 - Prospective Evaluation of Immunological, Molecular-genetic, Image-based and Microbial Analyzes to Characterize Tumor Response and Control in Patients With Inoperable Stage III NSCLC Treated With Chemoradiotherapy Followed by Consolidation Therapy With Durvalumab
Not yet recruiting NCT02931136 - Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging Phase 4
Not yet recruiting NCT03739892 - Biomarkers to Predict Gain From Therapy in Motor Stroke N/A
Recruiting NCT03801681 - ARrhythmias in MYocarditis
Recruiting NCT05372965 - The Effects of Smoking on miRNA-223 Before-After Non-Surgical Periodontal Therapy in Patients With Stage-3, Grade-B Periodontitis N/A
Completed NCT04772495 - miRNA Biomarkers in Multiple Sclerosis
Active, not recruiting NCT06178692 - Validation Study of a Serum-miRNA Signature in Glioma Patients.
Recruiting NCT05090410 - Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate Phase 3
Not yet recruiting NCT05764356 - Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II
Recruiting NCT02201446 - The Role of Circulating Soluble CD74 in Acute Lung Injury N/A
Not yet recruiting NCT05752890 - A Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma
Completed NCT04786431 - Shotgun Mass Spectrometry-based Lipid Profiling in Chronic Inflammatory Diseases