Effective and safe examination of Luseogliflozin for patients with fatty liver merger type II diabetes mellitus
- Conditions
- fatty liver merger type II diabetes mellitus
- Registration Number
- JPRN-UMIN000021087
- Lead Sponsor
- akakinen Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1)A diabetic except the type 2 2)The patient who corresponds to the taboo in the attached document of Luseogliflozin 3)The patient who is complicated with a serious renal damage 4)A patient with BMI less than 22kg/m2 5)Is the patients using Insulin, GLP-1 receptor agonist, SGLT2 inhibitor or Thiazolidine within eight weeks for observation period before initiation 6)Viral hepatitis (HBs antigen positive, HCV antibody positive), autoimmune hepatitis, the patients with primary biliary cirrhosis 7)Ascites, hepatic encephalopathy, the patients with the jaundice 8)The patients who put on strong magnetic substance and an electronic device including the body such as pacemakers 9)A pregnant woman, nursing mother, the patients who may be pregnant 10)The patients whom drinking that is the way the quantity of excessive alcohol goes is found in 11)By confirmation of the accumulation situation of intrahepatic iron by Chie Malle Coe T2*W1 of the MRI imaging, the evaluation of the intrahepatic fat ratio is clearly difficulty and the judged patient 12)The patients who, in addition, judged that study doctor attending was inadequate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. It is the amount of change of 24 weeks after the dosage from a baseline of HbA1c 2.It is the rate of change of 24 weeks after the dosage from the baseline of the fat ratio in the liver
- Secondary Outcome Measures
Name Time Method 1.A blood sugar parameter:HbA1c(other than 24 weeks time),fasting plasma glucose, fasting CPR, fasting insulin, HOMA2-B, HOMA2-S 2.Liver function parameter:AST, ALT, gamma-GTP, ALP, LDH, Alb, T-Bil, TP 3.A metabolic parameter concerned:The weight, the stomach neighborhood, SBP, DBP, TG, LDL-C, HDL-C, TC, FFA, Non-HDL-C,uric acid 4.Others:Ratio,fatty liver,liver fibrosis evaluation score (FLI,FIB-4 index,NFS,AAR) of the subject whom metabolic syndrome improved,type IV collagen 7S,ferritin,Mac-2bp