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Cigarette Smoking in Non-alcoholic Steatohepatitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04688307
Enrollment
104
Registered
2020-12-29
Start date
2017-11-01
Completion date
2018-12-01
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Steatohepatitis, Smoking, Aminotransferase

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.

Interventions

BEHAVIORALMotivational interviewing

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

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Liver fat content percent change from baseline to 6 months6 monthsLiver fat content percent changes calculated by a formula

Secondary

MeasureTime frameDescription
Serum alanine aminotransferase level changes form baseline to 6 months6 monthsInternational unit per liter, Minimum value: 0, higher values show worse outcome

Other

MeasureTime frameDescription
Serum aspartate aminotransferase level changes form baseline to 6 months6 monthsInternational unit per liter, Minimum value: 0, higher values show worse outcome

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026