Effects of canagliflozin on renal oxygenation evaluated by BOLD MRI in patients with type 2 diabetes

JRCT ID: jRCTs051200047

Registered date:26/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 07/09/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Canagliflozin (100mg) is orally administered once a day

Outcome(s)

• Primary Outcome: The change in T2* value before and after canagliflozin treatmnet
• Secondary Outcome: The change in erythropoietin, fasting plasma glucose, HbA1c glycated albumin, albuminuria, proteinuria, urinary electrolytes (sodium, potassium, chloride), urinary tubular damage marker (beta 2MG, NAG), and resistance index before and after canagliflozin treatmnet

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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)

Exclude 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
11) Severe heart failure (NYHA class III or IV)
12) Patients who participate in any clinical trial except this trial
13) Patients whom principal investigator judges as inappropriate for the trial

Related Information

• Primary Sponsor: Mori Katsuhito
• Source(s) of Monetary Support: Mitsubishi Tanabe Pharma Corporation