Effect of inhibition selectivity for sodium/glucose cotransporter on Glomerulotubular regulation of sodium balance and circadian blood pressure rhythm.

Effect of inhibition selectivity for sodium/glucose cotransporter on Glomerulotubular regulation of sodium balance and circadian blood pressure rhythm. - Na balance and BP rhythm during the treatment with SGLT inhibitor.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024422

Enrollment

Registered

2016-10-16

Start date

2016-10-11

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 diabetic nephrology

Interventions

oral administration of Canagliflozin (100mg/day) once in the morning oral administration of Tofogliflozin (20mg/day) once in the morning

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) type 2 diabetes mellitus 2) age 20 or more, regardless of gender 3) outpatient and inpatient 4) target HbA1c <7.0% is not achieved after approximately 3 months treatment with metformin 5) documented informed consent

Exclusion criteria

Exclusion criteria: 1) GFR <30 30ml/min/1.73m2 or undergoing renal replacement therapy 2) severe ketosis, diabetic coma or pre-come 3) conditions with serious infection, perioperative period, and severe trauma 4) presence/possibility for pregnancy/lactation 5) GOT >100, or GPT >85 6) current treatment with rifampicin, phenytoin, phenobarbital, ritonavir 7) current treatment with digoxin 8) current treatment with probenecid 9) current treatment with insulin 10) chronic or acute urinary tract infection 11) any reason for ineligibility suggested by the attending doctor (history of allergic reaction to study medication; inability to drink sufficient water)

Design outcomes

Primary

Measure	Time frame
Decrease in night/day ratio of blood pressure during 8 week treatment with SGLT2 inhibitors (week 8)	—

Secondary

Measure	Time frame
1) increase in daytime urinary sodium excretion (day2) 2) decrease in glomerulotubular Na balance (SNa x GFR, tNa)(week8) 3) constancy of daily urinary Na excretion (week8) 4) sympathetic and parasympathetic nerve activity (assessed by heart rate variability)(day2,week8) 5) HbA1c (week8) 6) urine anion gap, serum bicarbonate concentration (day2,week8)	—

Countries

Japan

Contacts

Public ContactMiyoko Suzuki

Nagoya City University Hospital Clinical Research Management Center

clinical_research@med.nagoya-cu.ac.jp81-52-858-7215

Outcome results

None listed

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