Development of Biomarkers for Diabetic Nephropathy based on Exosome Multi-Omics Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005145

Enrollment

260

Registered

2020-06-17

Start date

2019-12-31

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The patients with type 2 diabetes visit the hospital annually for 4 years (total 4 times). The subjects receive a medical history, a physical examinations and blood/urine tests, annu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: • 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.)

Design outcomes

Primary

Measure	Time frame
Development and validation of biomarkers based on Exosome Multi-Omics that can diagnose diabetic nephropathy early and predict its progress	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactSo Young Park

Korea University Ansan Hospital

Outcome results