Investigation of the effect of empagliflozin on cardiac sympathetic and parasympathetic nerve activity in Japanese patients with type 2 diabetes

Investigation of the effect of empagliflozin on cardiac sympathetic and parasympathetic nerve activity in Japanese patients with type 2 diabetes - EMPYREAN study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029194

Enrollment

134

Registered

2017-09-19

Start date

2017-10-01

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 (type 2)

Interventions

Empagliflozin 10mg qD will be administrated in group EMPA. Empagliflozin could be used upto 25mg qD during 12-24 weeks after the administration. Sitagliptin 50mg qD will be administrated in group SIT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) DM Patients with 7.0%<HbA1c<10% under the conventional diet/exercise therapy 2) Patients treated without SGLT-2 or DPP-4 within 12 weeks

Exclusion criteria

Exclusion criteria: 1) Patients treated with insulin or GLP-1 analogue 2) Patients with eGFR<45mL/min/1.73m2 3) Patients with Afib 4) Patients implanted PM 5) Patients who treated with beta-blockers, alpha-blokers, Digoxis, and CCB.

Design outcomes

Primary

Measure	Time frame
Changes from the baseline in LF, HF, and LF/HF ratio at the 24 weeks after the treatment. LF and HF will be estimated by heart rate valiability from 24-hour Holer ECG dataset, calcurated by spectral analysis.	—

Countries

Japan

Contacts

Public ContactHirohiko Motoki

Shinshu University School of Medicine Department of Cardiovascular Medicine

hmotoki@shinshu-u.ac.jp0263-37-3486

Outcome results

None listed

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