Effect of SGLT-2 inhibitors on Hepatic Steatosis and Fibrosis Estimated by using Fibroscan with Type 2 Diabetes Suffering from Non-alcoholic Fatty Liver Disease

Effect of SGLT-2 inhibitors on Hepatic Steatosis and Fibrosis Estimated by using Fibroscan with Type 2 Diabetes Suffering from Non-alcoholic Fatty Liver Disease - STHENIC trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022155

Enrollment

Registered

2016-05-01

Start date

2016-05-01

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

Type 2 Diabetes Suffering from Non-alcoholic Fatty Liver Disease

Interventions

Additional treatment with SGLT-2 inhibitor (SGLT-2 inhibitor group) for 24 weeks administration. Aggressive conventional treatment (control). (Excluding treatment with SGLT-2inhibitor and increase

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes patients 2. Diagnosed fatty liver by sonography 3. Oral administration of metformin 4. Satisfying diagnostic criteria of NAFLD Patients were prospectively assigned to either additional treatment with SGLT-2 inhibitors(n=30) or aggressive conventional treatment (control, n=30) for 6 months.

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes 2) Severe diabetic complications such as ketoacidosis 3) Severe renal dysfunction(estimated glomerular filtration rate [eGFR] < 30 mL/min/) 4) Pregnant or nursing women and those who might be pregnant 5) Chronic heart failure, 6) Haemodialysis, 7) A history of stroke and cardiovascular events, 8) Any patient whom the investigator judged to be inappropriate for this study. Patients were given detailed explanations of the study protocol.

Design outcomes

Primary

Measure	Time frame
The change of hepatic steatosis between SGLT-2 inhibitors group(Additional treatment with SGLT-2 inhibitor) and control group (aggressive conventional treatment without SGLT-2 inhibitors) at 24 weeks after starting this trial.	—

Secondary

Measure	Time frame
The change of visceral fat area The change of body composition The change of endothelial function The change of NAFLD fibrosis score,NAFIC score,FIB-4index and M2BPGi The change of oxidative,apoptosis markers and inflammatory cytokines. These changes will be evaluated at base line, 24 weeks between two groups	—

Countries

Japan

Contacts

Public ContactKunihiro Suzuki

Dokkyo Medical University Endocrinology and Metabolism

kuni-s@dokkyomed.ac.jp0282-87-2150

Outcome results

None listed

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