Development of Biomarkers for Diabetic Nephropathy based on Exosome Multi-Omics Study
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005145
- Lead Sponsor
- Korea University Ansan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 260
? inclusion criteria (Type 2 diabetes)
• Type 2 diabetes patients aged 40-80
• Patients who have been followed for more than 2 years
• Patients whose albumin-creatinine ratio and estimated glomerular filtration rate were measured two or more times before consent to study participation.
• estimated glomerular filtration rate =30 ml/min/1.73m2
? Inclusion criteria (healthy adult)
• 40-80 years healthy adult without hypertension, diabetes and chronic kidney disease
• Subjects who have been followed for more than 2 years at the Korea University Ansan Hospital Genome Cohort (The Korean Genome and Epidemiology Study, KoGES)
• estimated glomerular filtration rate =60 ml/min/1.73m2
• Patients with type 1 diabetes or a history of diabetic ketoacidosis or end stage renal diseas
• Patients diagnosed with chronic kidney disease not related to diabetes
• Patients with uncontrolled blood pressure (systolic blood pressure > 180 mmHg even after taking antihypertensive drugs) or patients taking 4 or more antihypertensive drugs
• kidney transplant, single kidney, or genetic kidney disease
• History of dialysis or acute kidney damage
• Other severe systemic diseases or body mass index <18.5 kg / m2
• History of malignancy within the last 5 years
• Long-term use of nephrotoxic drugs (eg, non-steroidal anti-inflammatory drugs, lithium) (over 3 months)
• Use of steroids (over 3 weeks) or systemic immunosuppressants
• Subjects deemed inappropriate for clinical studies (pregnant women, severe systemic diseases, psychiatric patients, etc.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development and validation of biomarkers based on Exosome Multi-Omics that can diagnose diabetic nephropathy early and predict its progress
- Secondary Outcome Measures
Name Time Method Establish discovery and validation cohort;Development of diabetic nephropathy-specific biomarkers based on Exosome Multi-Omics in discovery cohort;Validation the usefulness and reproducibility of the newly discovered biomarkers in validation cohort