Pleiotropic Effects and Safety of Sodium glucose co-transporter 2 inhibitor versus sulfonylurea in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver

Not Applicable

• Conditions: Type 2 Diabetes and Non-alcoholic Fatty Liver

• Registration Number: JPRN-UMIN000020544
• Lead Sponsor: Kanazawa university hospital Department of Disease Control and Homeostasis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-13
• Study Completion: 2018-03-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Hepatic virus infections, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, haemochromatosis, antitrypsin deficiency, Wilsons disease, history of parenteral nutrition and use of drugs known to induce steatosis or hepatic injury caused by substance abuse and or the current or past consumption of more than 20 g of alcohol daily Hypersensitivity to or contraindication of glimepiride and tofogliflozin None type 2 diabetes Poorly controlled diabetes Repeated episodes of unexplained hypoglycemia Concomitant infection or planned surgery Poorly controlled hypertension Severe retinopathy Malignancy on an active therapeutic regimen or malignancy without complete remission or cure Severe health problems not suitable for the study Pregnant or lactating women Inability to participate in the study as assessed by the investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The improvement in histologic features of NAFLD, as assessed with a composite of standardized scores for steatosis, lobular inflammation, hepatocellular ballooning, and fibrosis. Disease activity is assessed with the nonalcoholic fatty liver disease activity score, which is based on a standardized grading system for steatosis (on a scale of 0 to 3), lobular inflammation (on a scale of 0 to 3), and hepatocellular ballooning (on a scale of 0 to 2), with higher scores indicating increasing severity.