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The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride

Not Applicable
Conditions
onalcoholic fatty liver disease patients with type 2 diabetes
Registration Number
JPRN-UMIN000021291
Lead Sponsor
Kawasaki Medical SchoolKawasaki Medical School Devision of Diabetes, Endocrinology and Metabolism
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
90
Inclusion Criteria

Not provided

Exclusion Criteria

A) Under 20 years old B) Treatment with insulin C) Treatment with SGLT-2 inhibitor, thiazolidinedione or sulfonylurea D) Diabetic coma E) Renal dysfunction (eGFR<45mL/min) F) Cardiac failure G) Viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, liver cirrhosis H) Infection I) During treatment or treatment plan of malignant neoplasm J) Autoimmune disease K) Use of Steroid medicine and/or immunosuppressor L) Pregnant, possibility of pregnancy, nursing or hope to become pregnant during the study period M) In addition, when principal investigator or researcher deems inappropriate as a study subject

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change of liver function and L/S ratio (CT) six months after the intervention
Secondary Outcome Measures
NameTimeMethod
Change of body weight, visceral fat amount, fasting plasma glucose (FPG), insulin, triacylglycerol (TG), non-esterified fatty acid (NEFA), HDL-cholesterol, LDL-cholesterol, lipoprotein fractionation, adiponectin, hsCPR, TNF-alpha, MCP-, MDA, typIV collagen7S, P-III-P, M2BP, the fibrosis score (NAFLD fibrosis score, FIB-4 index, APRI, BARD score, BAAT score), proinsulin/S-CPR ratio
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