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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle modification and smoking reduction failure | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interviewing | Behavioral | Motivational interviewing for smoking reduction and adherence to diet and physical activity for obtaining ideal body weight |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum aspartate aminotransferase level changes form baseline to 6 months | International unit per liter, Minimum value: 0, higher values show worse outcome | 6 months |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Raika Jamali, MD | TUMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology clinic, Sina hospital. | Tehran | Iran | ||||
| Sina Hospital, TUMS |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Tehran |
| Iran |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |