Effect of canagliflozin on urinary albumin excretion in type 2 diabetic patients with microalbuminuria (pilot study)
Not Applicable
- Conditions
- Type 2 diabetic patients with microalbuminuria
- Registration Number
- JPRN-UMIN000023959
- Lead Sponsor
- akakinen clinic Medical Corporation Kensei-kai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1. Type 1 diabetes 2. The following drugs are administered (the date of submission of informed consent)SGLT2 inhibitor Insulin GLP-1receptor agonist 3. History of hypersensitivity to canagliflozin 4. Has severe ketosis, diabetic coma or semi-coma 5. Has severe infection, trauma or perioperative 6. Possible or definitive pregnant women or nursing mother 7. Has malignant tumor or suspicious for 8. Has urinary tract infection 9. Has NYHA class IV heart failure 10. Has severe anemia 11. Considered not eligible for the study by principal or other investigators due to other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in the 24-hour urine albumin excretion level (mg/day) from baseline to 12 weeks.
- Secondary Outcome Measures
Name Time Method Changes or percent changes in the following markers from baseline to 12 weeks. 1) HbA1c, fasting blood glucose 2) Body weight, BMI 3) eGFR (by serum creatinine, serum cystatin C), creatinine clearance 4) Urinary albumin (first morning voids, creatinine ratio) 5) Tubular and glomerular damage marker: Urinary type IV collagen, urinary transferrin, urinary NAG, urinary L-FABP, urinary B2 microglobulin, urinary NGAL, urinary KIM-1, serum TNFR1, serum TNFR2 6) Inflammatory marker: Serum IL-18, Serum high-sensitivity C-reactive protein 7) Oxidative stress marker: Urinary 8-OHdG 8) Blood pressure, serum uric acid, urinary aldosterone, serum aldosterone, plasma renin activity 9) Hematocrit 10) Serum erythropoietin 11) Absolute change in the 24-hour urine albumin (mg/day)