Cigarette Smoking in Non-alcoholic Steatohepatitis

Tehran University of Medical Sciences104 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

Motivational interviewingBEHAVIORAL

Motivational interviewing for smoking reduction and adherence to diet and physical activity for obtaining ideal body weight

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Gastroenterology clinic, Sina hospital.

Tehran, Iran

Sina Hospital, TUMS

Tehran, Iran

Outcomes

Primary Outcomes

Liver fat content percent change from baseline to 6 months

Liver fat content percent changes calculated by a formula

Time frame: 6 months

Secondary Outcomes

Serum alanine aminotransferase level changes form baseline to 6 months

International unit per liter, Minimum value: 0, higher values show worse outcome

Time frame: 6 months

Data from ClinicalTrials.gov

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