fatty liver merger type II diabetes mellitus
Conditions
Interventions
Luseogliflozin tab. 2.5mg/day
Sponsors
Nakakinen Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)The patient that an agreement was provided in a document than the person about the participation of this study 2) Age is a patient of (at the time of the document agreement acquisition) 20 years old or older 3) A patient having less than 8.5% of HbA1c (NGSP level) of the observation period more than 6.5% 4) The patient who carries out a constant diet cure continuously for more than start eight weeks for the observation period 5) The patient who does not use a diabetes therapeutic drug for more than start eight weeks for the observation period or the patient who uses diabetes therapeutic drug one drug or two drugs at a constant use, dose continuously for more than start eight weeks for the observation period 6) A patient (satisfying higher than following two items) that fatty liver was doubted by abdominal ultrasonography Rise in echo level of the liver parenchyma Upswing in liver kidney contrast Deep part decrement Obnubilation of the vessels in the liver
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKensuke Ofuchi
Practice part Clinical Research Department
Outcome results
None listed