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Cigarette Smoking in Non-alcoholic Steatohepatitis

NCT ID: NCT04688307

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifestyle modification and smoking reduction failure

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

Group Type EXPERIMENTAL

Motivational interviewing

Intervention Type BEHAVIORAL

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

Lifestyle modification and smoking reduction

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

Group Type EXPERIMENTAL

Motivational interviewing

Intervention Type BEHAVIORAL

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

Interventions

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Motivational interviewing

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Raika Jamali, MD

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raika Jamali, MD

Role: PRINCIPAL_INVESTIGATOR

TUMS

Locations

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Gastroenterology clinic, Sina hospital.

Tehran, , Iran

Site Status

Sina Hospital, TUMS

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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9411160001

Identifier Type: -

Identifier Source: org_study_id