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Cigarette Smoking in Non-alcoholic Steatohepatitis

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Motivational interviewing

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Steatohepatitis, Smoking, Aminotransferase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Gastroenterology clinic, Sina hospital.
Sina Hospital, TUMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Lifestyle modification and smoking reduction failure

Lifestyle modification and smoking reduction

Arm Description

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

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

Outcomes

Primary Outcome Measures

Liver fat content percent change from baseline to 6 months

Liver fat content percent changes calculated by a formula

Secondary Outcome Measures

Serum alanine aminotransferase level changes form baseline to 6 months

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

Full Information

NCT ID

NCT04688307

First Posted

November 1, 2019

Last Updated

October 13, 2021

Sponsor

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04688307

Brief Title

Cigarette Smoking in Non-alcoholic Steatohepatitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

November 1, 2018 (Actual)

Study Completion Date

December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Fatty Liver Disease

Keywords

Steatohepatitis, Smoking, Aminotransferase

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle modification and smoking reduction failure

Arm Type

Experimental

Arm Description

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

Arm Title

Lifestyle modification and smoking reduction

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Motivational interviewing

Intervention Description

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

Primary Outcome Measure Information:

Title

Liver fat content percent change from baseline to 6 months

Description

Liver fat content percent changes calculated by a formula

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Serum alanine aminotransferase level changes form baseline to 6 months

Description

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

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Serum aspartate aminotransferase level changes form baseline to 6 months

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raika Jamali, MD

Organizational Affiliation

TUMS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gastroenterology clinic, Sina hospital.

City

Tehran

Country

Iran, Islamic Republic of

Facility Name

Sina Hospital, TUMS

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cigarette Smoking in Non-alcoholic Steatohepatitis

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