Cigarette Smoking in Non-alcoholic Steatohepatitis

Study Overview
=================
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.

Official Title
-----------------
The Effect of Cigarette Smoking Reduction on Liver Function Tests and Metabolic Profile in Subjects With Non-alcoholic Steatohepatitis

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Behavioral: Motivational interviewing


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle modification and smoking reduction failure<br>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 | Behavioral: Motivational interviewing<br>* Motivational interviewing for smoking reduction and adherence to diet and physical activity for obtaining ideal body weight<br>|
| Experimental: Lifestyle modification and smoking reduction<br>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 | Behavioral: Motivational interviewing<br>* Motivational interviewing for smoking reduction and adherence to diet and physical activity for obtaining ideal body weight<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fat content percent change from baseline to 6 months | Liver fat content percent changes calculated by a formula | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum alanine aminotransferase level changes form baseline to 6 months | International unit per liter, Minimum value: 0, higher values show worse outcome | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Steatohepatitis, Smoking, Aminotransferase