Table 2. Patient inclusion and exclusion criteria.
Inclusion criteria | Exclusion criteria | |
1 | Men and women aged at least 20 years and under 80 years at the time of obtaining consent | Patients taking contraindications.Ciclosporin, rifampicin, steroids (excluding topical and inhaled drugs), amiodarone and breast cancer drugs. |
2 | Patients with fatty liver diagnosed histologically within 1 year prior to obtaining consent or imaging examination within 6 months prior to obtaining consent and who have failed exercise and diet therapy for at least 3 months. | Patients with body mass index <18.5 kg/m2 at the time of obtaining consent. |
3 | Patients with hypertriglyceridaemia (150–500 mg/dL) within 91 days prior to obtaining consent. | Patients who have been diagnosed with liver cirrhosis at the time of obtaining consent |
4 | Patients with elevated alanine aminotransferase (43–100 IU/L for men, 24–100 IU/L for women) within 91 days prior to obtaining consent. | Patients with findings of portal hypertension (varicose veins, ascites, encephalopathy and splenomegaly) at the time of obtaining consent. |
5 | Patients whose daily alcohol consumption (ethanol equivalent) is less than 30 g/day for men and less than 20 g/day for women at the time of obtaining consent | Patients with total bilirubin >2× the upper limit of normal within 91 days prior to obtaining consent, excluding Girbert syndrome. |
6 | Patients with hepatitis C, hepatitis B (excluding inactive carriers), autoimmune hepatitis, primary biliary cholangitis or other hepatic complications that have been ruled out at the time of obtaining consent. | Platelet count 80×109/L within 91 days prior to obtaining consent. |
7 | Patients whose written consent to participate in this study has been obtained. | Serum creatinine level of 1.5 mg/dL or higher within 91 days prior to obtaining consent. |
8 | Patients with gallstones or biliary obstruction at the time of obtaining consent. | |
9 | Patients with severe infection, preoperative or postoperative or severe trauma at the time of obtaining consent. | |
10 | Patients who have used fibrates within 91 days prior to obtaining consent. | |
11 | Patients with 10% weight change in 91 days prior to obtaining consent. | |
12 | Patients who have undergone bariatric surgery or are scheduled for surgery during the study period. | |
13 | Patients with a history of type I diabetes mellitus. | |
14 | Patients with HbA1c >9.5% within 91 days prior to obtaining consent(If HbA1c >9.5%, re-entry will be possible after improvement by treatment.). | |
15 | Patients with psychosis, alcoholism, drug addiction or narcotic addiction that would affect compliance with the research protocol. | |
16 | Patients who participated in other clinical trials in 100 days prior to obtaining consent. | |
17 | Pregnant women or patients who may be pregnant. | |
18 | Patients with complications of malignant tumoursHowever, patients who have undergone radical surgery or completed anticancer drug administration may enrol. Patients under observation and evaluation for malignant tumours are excluded. | |
19 | Other patients who are judged by the principal investigator to be inappropriate as participants of this study. |
HbA1c, haemoglobin A1c