Non-diabetic Patients with Nonalcoholic Steatohepatitis
Conditions
Interventions
Group 1:Daily energy intake as 1600-1700kcal for male patients and 1300-1400kcal for female patients combined with Vitamin E soft gel treatment in a dose of 100mg bid,PO. Continue this management 7 da
Group 2:2 days per week with Daily energy intake as 500-600kcal, and the rest 5 days with normal diet(2250kcal/day for male patients and 1800kcal/day for female patients) combined with Vitamin E soft
Sponsors
the First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years old male and female; 2. BMI<35 kg/m2; 3. Patients with NASH based on liver biopsy obtained within 6 months before randomization.According to the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN), the NASH activity score(NAS) is defined as follows: (1) Stetosis =1 (=5%); (2) Lobular inflammation =1; (3) Hepatocyte ballooning =1; (4) NAS( stetosis + lobular inflammation + hepatocyte ballooning) =4; 4. Fibrosis stage 0–3 according to NASH CRN(the upper and lower limits are included); 5. No history of significant alcohol consumption for a period of more than 5 years (<10 g/day for women and <20 g/day for men); 6. The laboratory test results should meet the following requirements before randomization: (1) ALT < 5 times of normal upper limit; (2) creatinine(Cr) = normal upper limit; (3) albumin (ALB) = 35 g/L; (4) international normalized ratio (INR) of coagulation function = 0.8–1.3; (5) fasting plasma glucose (FPG) < 126 mg/dL (7 mmol/L) and/or 2 h postprandial blood glucose (2hPPG) < 200 mg/dL (11.1 mmol/L); 7. Hypertension patients will be required to take a stable antihypertensive drug(s) to keep blood pressure stable (<140/90 mmHg) 3 months prior to randomization; 8. If a participant is using a statin or fibrate, he/she will be required to be on a fixed dose to keep lipids stable: triglyceride (TG) < 1.7 mmol/L, total cholesterol (TC)< 6.00 mmol/L, low density lipoprotein cholesterol (LDL-c) < 4 mmol/L, 3 months prior to randomization; 9. Female participants should meet the requirement as follows: (1) post-menopause ( defined as no menstruation in at least 1 year) or, (2) after sterilization operation or, (3) fertile but with negative blood pregnancy test before randomization and are willing to use contraception beginning from the date of signing the informed consent form to the date of the end of follow-up visits; 10. Male participants should agree to use contraception methods beginning from the date of signing the informed consent form to the date of the end of follow-up visits; 11. All participants understand and agree to sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1)With other acute or chronic active liver diseases such as viral hepatitis, hereditary hemochromatosis, hepatolenticular degeneration, alpha-antitrypsin deficiency, alcoholic liver disease, drug-induced liver diseases, etc.; (2) History of diabetes mellitus and treatment with any antidiabetic drugs; (3) Known heart failure of New York Heart Association class 2, 3, or 4; (4) Known acceptance of cardiac pacemaker implantation; (5) With uncontrolled hypothyroidism (serum level of thyroid-stimulating hormone is 2 times higher than the upper limit of normal value); (6) History of diseases influencing food/drug absorption, distribution, and metabolism such as inflammatory bowel disease, gastrointestinal surgery, chronic pancreatitis, gluten allergies, vagotomy, etc.; (7) Evidence of positive human immunodeficiency virus antigen or antibody (HIV-Ag/Ab); (8) Known vitamin E allergy or intolerance; (9) Poor compliance with self-dietary management and exercise program; (10) Alcoholics and/or drug abuser; (13) Any other diseases or conditions that the investigator considers make patients unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight;Waist circumference;Hip circumference;FibroScan;Liver biopsy; | — |
Countries
China
Contacts
Public ContactZheng Ming-Hua
the First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed