Cigarette Smoking in Non-alcoholic Steatohepatitis

Not Applicable

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Behavioral: Motivational interviewing

• Registration Number: NCT04688307
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-11-01
• Study Completion: 2018-12-01
• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle modification and smoking reduction failure	Motivational interviewing	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
Lifestyle modification and smoking reduction	Motivational interviewing	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

Primary Outcome Measures

Name	Time	Method
Liver fat content percent change from baseline to 6 months	6 months	Liver fat content percent changes calculated by a formula

Secondary Outcome Measures

Name	Time	Method
Serum alanine aminotransferase level changes form baseline to 6 months	6 months	International unit per liter, Minimum value: 0, higher values show worse outcome

Trial Locations

Locations (2)

Gastroenterology clinic, Sina hospital.; 🇮🇷 Tehran, Iran, Islamic Republic of

Sina Hospital, TUMS; 🇮🇷 Tehran, Iran, Islamic Republic of