Cigarette Smoking in Non-alcoholic Steatohepatitis

NCT04688307 | Completed

• 1 other identifier: 9411160001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Steatohepatitis; Smoking; Aminotransferase

Outcome Measures

Primary Outcomes (1)

• Liver fat content percent change from baseline to 6 months

  Liver fat content percent changes calculated by a formula

  6 months

Secondary Outcomes (1)

• Serum alanine aminotransferase level changes form baseline to 6 months

  6 months

Other Outcomes (1)

• Serum aspartate aminotransferase level changes form baseline to 6 months

  6 months

Study Arms (2)

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

Behavioral: Motivational interviewing

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

Behavioral: Motivational interviewing

Interventions

Motivational interviewing BEHAVIORAL

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

Lifestyle modification and smoking reduction; Lifestyle modification and smoking reduction failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokers with persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (2)

Gastroenterology clinic, Sina hospital.

Tehran, Iran

Location

Sina Hospital, TUMS

Tehran, Iran

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Smoking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Raika Jamali, MD

  TUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: December 29, 2020
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)