Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000025771
- Lead Sponsor
- Dokkyo Medical University Nikko Medical Center Department of Clinical Study Support Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 90
Not provided
(a) Patients with type 1 diabetes mellitus (b) Patients with a medical history of hypersensitivity to any of the ingredients of dapagliflozin (c) Patients with severe ketosis or diabetic coma or pre-coma (d) Patients who have severe infection, are pre- or postoperative, or have sustained serious trauma (e) Patients with severe impaired liver function (f) Patients who are susceptible to dehydration (g) Patients with urinary tract infection or genital infection (h) Patients with a history of cerebrovascular disease within the last 3 months (i) Women who are pregnant or breastfeeding or who may be pregnant (j) Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 mL (k) Patients on warfarin or a novel oral anticoagulant (NOAC) (dabigatran, rivaroxaban, edoxaban, or apixaban) (l) Current smokers (m) Patients otherwise deemed to be unsuitable for the clinical study by investigators
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 the microchannel array flow analyzer (MC-FAN) equipped with BK 7-7-7D chip
- 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 using F.R.E.E. carpe diem (Diacron srl, Grosseto, Italy) 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 (0.1 mL) did not increase =>6.0sec(15%), as determined using MC-FAN at 8 and 16 weeks after enrollment