Non-Alcoholic Fatty Liver DiseaseNCT04688307
Cigarette Smoking in Non-alcoholic Steatohepatitis
A study testing Motivational interviewing in people with Non-Alcoholic Fatty Liver Disease, run by Tehran University of Medical Sciences at 2 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesIran
- Study dates
- 1 Nov 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smokers with persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Gastroenterology clinic, Sina hospital.
Tehran
Sina Hospital, TUMS
Tehran
About this study
Official title: The Effect of Cigarette Smoking Reduction on Liver Function Tests and Metabolic Profile in Subjects With 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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Motivational interviewing
- Keywords
- Steatohepatitis, Smoking, Aminotransferase
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
Motivational interviewing for smoking reduction and adherence to diet and physical activity for obtaining ideal body weight
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content percent change from baseline to 6 months
Liver fat content percent changes calculated by a formula
Measured: 6 months
Secondary outcomes (1)
Serum alanine aminotransferase level changes form baseline to 6 months
International unit per liter, Minimum value: 0, higher values show worse outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Nov 2017
- Primary completion1 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raika Jamali, MD, Tehran University of Medical Sciences
- Investigators
- Raika Jamali, MD, Principal investigator, TUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688307
- Sponsor's protocol ID
- 9411160001
- Status last verified
- Oct 2021
- First submitted
- 1 Nov 2019
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cigarette Smoking Reduction on Liver Function Tests and Metabolic Profile in Subjects With Non-alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT04688307
- Acronym / sponsor ID
- 9411160001
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Steatohepatitis, Smoking, Aminotransferase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification and smoking reduction failure | Experimental | Behavioral: Motivational interviewingObtaining 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 |
| Lifestyle modification and smoking reduction | Experimental | Behavioral: Motivational interviewingObtaining 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smokers with persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingMotivational interviewing for smoking reduction and adherence to diet and physical activity for obtaining ideal body weight | Behavioural | Lifestyle modification and smoking reduction, Lifestyle modification and smoking reduction failure |
Primary outcome
Liver fat content percent change from baseline to 6 months
Time frame: 6 months
Liver fat content percent changes calculated by a formula
1 secondary outcome
Serum alanine aminotransferase level changes form baseline to 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raika Jamali, MD principal investigator
TUMS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Non-Alcoholic Fatty Liver Disease, run by Tehran University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content percent change from baseline to 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.