Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress
Not Applicable
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCTs071180044
- Lead Sponsor
- Yasu Takanori
- Brief Summary
Hepatocrit was increased by about 2% after 16 weeks of dosage of depagliflosin in type 2 diabetes patients, but proved to be inferior in terms of blood fluidity compared to the conventional treatment group. Concerning safety, the attending physician conducted examination data, interviews, etc. at each visit at each visit to continuously check for adverse events and subjective symptoms, and to ensure the safety of subjects through monitoring.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Type 2 diabetes mellitus patient, with HbA1c>7.0%, Diabetic nephropathy stage <=3
Exclusion Criteria
Patients with type 1 diabetes mellitus
Patients with a medical history of hypersensitivity to any of the ingredients of dapagliflozin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Whole blood transit time (0.1 mL) and the difference from baseline at 16 weeks after enrollment, as assessed using microchannel array flow analyzer (MC-FAN) equipped with BK 7-7-7D chip<br>Assessment method of primary outcome: Six sec (15%) noninferiority margin (clinically significant cut-off value) will be used. The 95% confidence interval of the difference from baseline will be calculated using the t-distribution to test noninferiority.
- Secondary Outcome Measures
Name Time Method Blood samples at 8 and 16 weeks after enrollment (whole blood transit time (0.1 mL) and difference from baseline as determined using the MC-FAN with DKAMCM1-60-7-4.5D, leukocyte activation (adhesive leukocyte count as determined using the MC-FAN with DKAMCM1-60-7-4.5D , difference between whole blood transit time in heparin (5% vol) blood samples and whole blood transit time in EDTA-2Na + heparin blood samples as determined using the DKAMCM1-60-7-4.5D), CBC, lipid system, hsCRP, serum creatinine, hydroperoxide levels as serum levels of reactive oxygen metabolite (d-ROM) and antioxidant potencial as determined by BAP test), and urine samples (albuminuria assay); whole blood transit time (0.1 mL) and difference from baseline as determined using the MC-FAN 7-7-7D chip at 8 weeks after enrollment: and percentage in which whole blood transit time (0.1mL) did not increase 6.0sec(15%) as determined using MC-FAN at 8 and 16 weeks after enrolment.