urinary exosomal microRNA marker for progressive diabetic nephropathy

Not Applicable

Recruiting

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0003573
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Type 2 diabetic patients diagnosed at the age of 30 or older
- Aged 75 and younger
- Patients with eGFR and albuminuria recordings at least three times in intervals of at least 3 months
- Patients taking antihypertensive agents and angiotensin converting enzyme (ACE) inhibitor / angiotensin II receptor blocker (ARB) for hypertension or albuminuria have been receiving stable doses for more than 2 weeks

As a healthy healthy control group, adult subjects who aged more than 30 and 75 or less years old, with neither diabetes nor chronic kidney disease

Exclusion Criteria

? Under the age of 30 or over 75 years old
? Patients with type 1 diabetes or diabetic ketoacidosis
? Patients with CKD unrelated to diabetes
? Patients with poor blood pressure control or those taking 4 or more classes of antihypertensive drugs
? Patients with kidney transplantation or single kidney, patients with genetic kidney disease
? Among retrospective trajectory data, initial urine albumin/creation ratio (UACR)> 3500 mg/g, hemoglobin <11 g/dL, or serum albumin <3.6 g/dL
? Hemoglobin A1c level> 11.0% at enrollment,
? A history of dialysis or a history of acute kidney injury
? Other severe systemic disease or BMI <18.5 kg /square meters
? Pregnant women
? Malignant diseases with the last 5 years
? Long-term use (3 or more months) of nephrotoxic agents (e.g., NSAID and lithium)
? The use of Steroids(for 3 or more weeks) or systemic immunosuppressant dosage
? Patients who are considered inappropriate due to other clinical studies (eg, severe systemic disease, mental illness, social anxiety, etc.)
? End-stage renal disease before enrollment

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MicroRNA profiles associated with the progression of diabetic nephropathy

Secondary Outcome Measures

Name	Time	Method
Predictive performance of the combination of selected microRNA markers and clinical variables for progressive diabetic nephropathy