The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy

The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy - The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033541

Enrollment

200

Registered

2018-07-28

Start date

2018-10-01

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

diabetes mellitus

Interventions

Adiministration of SGLT2 inhibitors (empagliflozin 10mg/day or tofogliflozin 20mg/day) for three months of phase II cardiac rehabilitation Adiministration of diabetic medication other than SGLT2 inhib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Diagnosed as type 2 diabetes mellitus with fasting blood glucose >=126mg/dL (or casual blood glucose >=200mg/dL) and HbA1c >=6.5% (2) HbA1c >=7.0% at the beginning of cardiac rehabilitation (3) Age >=20 years old and <90 years old (4) Providing written informed consent on voluntary basis

Exclusion criteria

Exclusion criteria: (1) History of SGLT2 inhibitor treatment (2) Associated with severe renal dysfunction (3) Associated with respiratory disease (4) History of cerebral infarction (5) History of urinary / genital infection (6) Women in pregnancy or at risk of becomming pregnant (7) Breast-feeding woment (8) Patients whom researchers rule out as prropriate subjects

Design outcomes

Primary

Measure	Time frame
Heart rate recovery after exercise, heart rate variability parameters after three months of SGLT2 inhibitor treatment	—

Countries

Japan

Contacts

Public ContactMiyu Tajima

Sakakibara Heart Institute Cardiovascular department

mtajima-tky@umin.ac.jp042-314-3111

Outcome results

None listed

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