Cigarette Smoking in Non-alcoholic Steatohepatitis

Tehran University of Medical Sciences

Status: Completed

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: Motivational interviewing

Study type: Interventional

Funder types: Other

Identifiers

NCT04688307

9411160001

Details and patient eligibility

About

This non-randomized clinical trial was performed to clarify the effect of cigarette smoking reduction on liver function and some anthropocentric indices in smoker patients with non-alcoholic steatohepatitis.

Full description

After excluding other causes of high aminotransferase level, participants with persistent elevated serum aminotransferase levels and evidence of fatty liver in ultrasonography were presumed to have non-alcoholic steatohepatitis. Those with NAFLD liver fat score greater than (-0.64) were enrolled. They were assigned to lifestyle modification alone or lifestyle modification plus smoking reduction groups.

Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Smokers with persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.

Exclusion criteria

• alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
• heart disease (ischemic or congestive),
• hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion),
• renal disease (serum creatinine concentration of > 1.5 mg/dl),
• any severe systemic co-morbidities, neoplasm,
• using any hepatotoxic medication during the past 3 months,
• pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Lifestyle modification and smoking reduction failure

Experimental group

Description:

Obtaining ideal body weight by calorie restriction diet and programmed physical activity and the amount of cigarette smoking reduction is not more than 50% of the baseline

Treatment:

Behavioral: Motivational interviewing

Lifestyle modification and smoking reduction

Experimental group

Description:

Obtaining ideal body weight by calorie restriction diet and programmed physical activity and the amount of cigarette smoking reduction is 50% of the baseline or more

Treatment:

Behavioral: Motivational interviewing