Effects of canagliflozin, SGLT2 inhibitor, on renal oxygenation evaluated by blood oxygenation level-dependent (BOLD) MRI in patients with type 2 diabetes: An open-label, single-arm trial - Diamond study-8

Mori Katsuhito0 sites14 target enrollmentAugust 26, 2020

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Mori Katsuhito
Enrollment: 14
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Although results obtained in recent large clinical trials suggest protective effects of SGLT2 inhibitors on the kidneys, the precise mechanisms are largely unknown. We speculated that use of an SGLT2 inhibitor improves renal oxygenation. Thus, the effect of canagliflozin on renal oxygenation was examined using BOLD MRI. The findings indicate that canagliflozin may improve renal cortical oxygenation in patients with T2D.

Registry

who.int

Start Date

August 26, 2020

End Date

March 2, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Mori Katsuhito

Eligibility Criteria

Inclusion Criteria

•1\) Type 2 diabetes
•2\) Signed consent form
•3\) Age \>\= 20 years and \< 80 years
•4\) HbA1c level \>\= 6\.5% and \< 10%
•5\) Patients without any SGLT2 inhibitors at least 2 weeks before first BOLD MRI (at least 17 days before first canagliflozin administration)

Exclusion Criteria

•1\) Pregnancy or breat\-feeding and its possibility
•2\) Known allergy to canagliflozin
•3\) Contraindication for MRI (pacemaker or claustrophobia)
•4\) Past history of recurrent urinary tract or genital infections
•5\) Nephrotic sydrome
•6\) Diuretics or NSAIDs
•7\) Severe renal dysfuntion (eGFR \< 30 mL/min/1\.73m2\) or end\-stage renal disease (dialysis) or renal transplantation
•8\) Renal morphological abnormality such as several cysts, hydronephrosis and abnormal calcification etc.
•9\) Severe hepatic dysfunction (AST or ALT \> triple upper limit of facility criterion)
•10\) Malignant tumors