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OpenTrials
Completed

NCT Number: NCT04688307

Cigarette Smoking in Non-alcoholic Steatohepatitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastroenterology clinic, Sina hospital., Tehran, Iran

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing

Behavioral

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

Primary outcomes

  1. Liver fat content percent change from baseline to 6 months

    Time frame: 6 months

    Liver fat content percent changes calculated by a formula

Secondary outcomes

  1. Serum alanine aminotransferase level changes form baseline to 6 months

    Time frame: 6 months

    International unit per liter, Minimum value: 0, higher values show worse outcome

Other outcomes

  1. Serum aspartate aminotransferase level changes form baseline to 6 months

    Time frame: 6 months

    International unit per liter, Minimum value: 0, higher values show worse outcome

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2020
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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