Effects of SGLT-2 inhibitors for the patients with non-alcoholic fatty liver disease (NAFLD) complicated with type 2 diabetes mellitus.

Effects of SGLT-2 inhibitors for the patients with non-alcoholic fatty liver disease (NAFLD) complicated with type 2 diabetes mellitus. - SGLT-2 and NAFLD/T2DM

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000018913

Enrollment

Registered

2015-09-04

Start date

2015-10-01

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

Non-alcoholic fatty liver disease (NAFLD) complicated with type 2 diabetes mellitus.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Uncontrolled Type 2 DM patients after 3 months of diet/exercise therapy 2) Diagnosed as fatty liver 3) BMI >/= 25kg/m2 4) GGT >/= 1.5 x normal limits 5) Need for SGLT-2 inhibitors administration 6) HbA1c >/= 6.5%

Exclusion criteria

Exclusion criteria: 1) History of allergy to SGLT-2 inhibitors 2) HB/HC/autoimmune hepatitis 3) Pregnancy or lactation in women 4) Under insulin treatment 5) Excess alcohol consumption male; >/= 30g/day female; >/= 20g/day 6) Inadequacy for this therapy

Design outcomes

Primary

Measure	Time frame
GGT	—

Secondary

Measure	Time frame
HbA1c, Body weight, HOMA-IR	—

Countries

Japan

Contacts

Public ContactSatoru Kakizaki

Gunma University Graduate School of Medicine Department of Medicine and Molecular Science

kakizaki@gunma-u.ac.jp027-220-8127

Outcome results