Cigarette Smoking in Non-alcoholic Steatohepatitis

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04688307
• Other study ID #: 9411160001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: October 2021
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Gastroenterology clinic, Sina hospital.	Tehran
Iran, Islamic Republic of	Sina Hospital, TUMS	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum aspartate aminotransferase level changes form baseline to 6 months	International unit per liter, Minimum value: 0, higher values show worse outcome	6 months
Primary	Liver fat content percent change from baseline to 6 months	Liver fat content percent changes calculated by a formula	6 months
Secondary	Serum alanine aminotransferase level changes form baseline to 6 months	International unit per liter, Minimum value: 0, higher values show worse outcome	6 months