Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress

Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress - Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071180044

Enrollment

Registered

2019-03-14

Start date

2017-04-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Type 2 diabetes mellitus Type 2 diabetes mellitus

Interventions

Dapagliflozin treatment group: Oral dapagliflozin 5 mg/day in combination with standard therapy (the dapagliflozin dose can be increased to 10 mg in subjects with inadequate response to 5 mg) Non-dapa

SGLT2 inhibitor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes mellitus patient, with HbA1c>7.0%, Diabetic nephropathy stage <=3

Exclusion criteria

Exclusion criteria: Patients with type 1 diabetes mellitus Patients with a medical history of hypersensitivity to any of the ingredients of dapagliflozin

Design outcomes

Primary

Measure	Time frame
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 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.	—

Measure

Time frame

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 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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactAkiko Niijima

Dokkyo Medical University Nikko Medical Center

aniijima@dokkyomed.ac.jp+81-288-76-1515

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026