Non-alcoholic Fatty Liver DiseaseNCT02679417
The Effects of Type of Exercise in Non-alcoholic Fatty Liver Disease
A study testing exercise in people with Non-alcoholic Fatty Liver Disease, run by Mahidol University at 1 site in Thailand.
Trial summary
The type of physical activity such as, aerobic or resistant exercise required to reduce liver fat content in patient with non-alcoholic fatty liver disease (NAFLD) remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2015to Sep 2016
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Siriraj medical personals
- Ultrasonography show liver steatosis by using ultrasound criteria
- Transient elastography by using the controlled attenuation parameter show moderate degree of fatty accumulation in the liver
- History of alcohol consumption in male <20 g/d, female <10 g/d
Who cannot join
- Liver disease of other etiology
- Medications that caused fatty accumulation in the liver
- Treated with vitamin E or antidiabetic agents
- Cardiopulmonary diseases or orthopedic conditions that are contraindicated for exercise
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
Official title: The Effects of Type of Exercise on Hepatic Fat Content and Metabolic Profiles in Non-alcoholic Fatty Liver Disease: A Randomized Trial
The type of physical activity such as, aerobic or resistant exercise required to reduce liver fat content in patient with non-alcoholic fatty liver disease (NAFLD) remains unclear. The purpose of this study is to determine whether aerobic exercise should provide improvement of hepatic fat content and inflammation as well as metabolic profiles and anthropometric parameters better than resistant exercise.
Read the detailed description
Increasing prevalence of overweight and obese worldwide, non-alcoholic fatty liver disease (NAFLD) is commonly diagnosed in daily clinical practice. Weight reduction has been the only strategy established thus far to reduce hepatic lipid levels. Thus, dietary restriction and exercise focusing on weight reduction is recommended as the cornerstone for managing NAFLD. Recent reports have indicated that increased exercise greatly reduces hepatic fat accumulation and inflammation and the related oxidative stress levels outweigh those achieved by dietary restriction alone. Clear guidelines for such a "lifestyle physical activity" for NAFLD management are currently lacking. The type of physical activity such as, aerobic or resistant exercise required to reduce liver fat content remains unclear.The purpose of this study is to determine whether aerobic exercise should provide improvement of hepatic fat content and inflammation as well as metabolic profiles and anthropometric parameters better than resistant exercise.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- exercise
- Keywords
- Aminotransferase, Fibrosis, liver, Anthropometry, Exercise
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
12 weeks of aerobic or resistant exercise
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise | Active comparator | Each participant reach a minimum of 50 minutes of some form of aerobic exercise including running on a treadmill 5 to 7 days per week for 12 weeks under the supervision of fitness center trainers. Receives: Behavioral: exercise |
| resistant exercise | Active comparator | Each participant reach a minimum of 50 minutes of some form of strength training involving repetitions of a resistance training exercise for each major muscle group at an intensity for at least 60% of a one-repetition max, 5 to 7 days per week for 12 weeks under the supervision of fitness center trainers. Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic fat content as assessed by the controlled attenuation parameter.
Hepatic fat content will be assessed with the controlled attenuation parameter (CAP) at baseline and the end of 12 weeks. The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements.
Measured: 12 weeks
Secondary outcomes (5)
Hepatic inflammation as assessed by serum levels of aspartate aminotransferase, alanine aminotransferase, ferritin and c-reactive protein.
Venous blood samples will be obtained for aspartate aminotransferase, alanine aminotransferase, ferritin and c-reactive protein to evaluate the evidence of hepatic inflammation at baseline, 4 weeks, 8 weeks and 112 weeks.
Measured: 12 weeks
Liver fibrosis as assessed by vibration-controlled transient elastography.
Liver fibrosis will be acquired by the FibroScan® M probe based on vibration-controlled transient elastography at baseline and the end of 12 weeks. Liver stiffness measurement will be performed by a single operator who is blinded to all clinical data of the patients. Ten successful acquisitions will be performed on each patient. The median value is considered representative of the elastic modulus of the liver expressed in kilopascal (kPa).
Measured: 12 weeks
Metabolic profiles assessed with the measurement of lipid profiles, plasma glucose, insulin and oral glucose tolerance test.
Venous blood samples will be obtained after a 12-hour overnight fast for total cholesterol, triglyceride, high density lipoprotein cholesterol, low density lipoprotein cholesterol, plasma glucose, insulin, and oral glucose tolerance test at baseline and the end of 12 weeks.
Measured: 12 weeks
Anthropometry and bioelectrical impedance assessed by a bioelectrical fat analyzer.
All anthropometric measurements will be performed with the subjects wearing light clothes without shoes at baseline, 4 weeks, 8 weeks and 12 weeks. Height will be measured to the nearest 0.01 m using a calibrated wall-mounted stadiometer. Body weight will be determined to the nearest 0.05 kg using a calibrated balance beam scale. Body mass index will be calculated as weight (kg) divided by the height-squared (m2). Body circumferences will be measured with a flexible tape, with the subject in the upright position at the end of a gentle expiration, at the following levels: waist (midway between the lower rib margin and the superior interior iliac spine) and hip (widest circumference over the great trochanters). Bioelectrical impedance analysis will be performed with the use of a bioelectrical fat analyzer at baseline, 4 weeks, 8 weeks and 12 weeks.
Measured: 12 weeks
Cardiorespiratory fitness as assessed with maximal oxygen uptake under treadmill test.
Cardiorespiratory fitness will be assessed by a trained health technician at baseline and the end of 12 weeks. The protocol of treadmill test include a 2-min warm-up, two 3-min exercise stages, and a 2-min cool down period. The protocol goal is to elicit a heart rate that is approximately 75% of the age-predicted maximum (220-age) by the end of the test. Heart rate will be monitored throughout the test, and blood pressure will be measured at the end of each stage. Maximal oxygen uptake (V·O2max) will be estimated using a calculation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phunchai Charatcharoenwitthaya, Mahidol University
- Investigators
- Phunchai Charatcharoenwitthaya, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679417
- Sponsor's protocol ID
- 183/2558(EC1)
- Status last verified
- Sep 2016
- First submitted
- 29 Jan 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.
PubMed 22488764Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30.
PubMed 21623852Beymer C, Kowdley KV, Larson A, Edmonson P, Dellinger EP, Flum DR. Prevalence and predictors of asymptomatic liver disease in patients undergoing gastric bypass surgery. Arch Surg. 2003 Nov;138(11):1240-4. doi: 10.1001/archsurg.138.11.1240.
PubMed 14609874Leite NC, Salles GF, Araujo AL, Villela-Nogueira CA, Cardoso CR. Prevalence and associated factors of non-alcoholic fatty liver disease in patients with type-2 diabetes mellitus. Liver Int. 2009 Jan;29(1):113-9. doi: 10.1111/j.1478-3231.2008.01718.x. Epub 2008 Apr 1.
PubMed 18384521Assy N, Kaita K, Mymin D, Levy C, Rosser B, Minuk G. Fatty infiltration of liver in hyperlipidemic patients. Dig Dis Sci. 2000 Oct;45(10):1929-34. doi: 10.1023/a:1005661516165.
PubMed 11117562Musso G, Gambino R, Cassader M, Pagano G. Meta-analysis: natural history of non-alcoholic fatty liver disease (NAFLD) and diagnostic accuracy of non-invasive tests for liver disease severity. Ann Med. 2011 Dec;43(8):617-49. doi: 10.3109/07853890.2010.518623. Epub 2010 Nov 2.
PubMed 21039302Hashimoto E, Yatsuji S, Tobari M, Taniai M, Torii N, Tokushige K, Shiratori K. Hepatocellular carcinoma in patients with nonalcoholic steatohepatitis. J Gastroenterol. 2009;44 Suppl 19:89-95. doi: 10.1007/s00535-008-2262-x. Epub 2009 Jan 16.
PubMed 19148800Promrat K, Kleiner DE, Niemeier HM, Jackvony E, Kearns M, Wands JR, Fava JL, Wing RR. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Hepatology. 2010 Jan;51(1):121-9. doi: 10.1002/hep.23276.
PubMed 19827166Sullivan S, Kirk EP, Mittendorfer B, Patterson BW, Klein S. Randomized trial of exercise effect on intrahepatic triglyceride content and lipid kinetics in nonalcoholic fatty liver disease. Hepatology. 2012 Jun;55(6):1738-45. doi: 10.1002/hep.25548. Epub 2012 Apr 25.
PubMed 22213436Hallsworth K, Fattakhova G, Hollingsworth KG, Thoma C, Moore S, Taylor R, Day CP, Trenell MI. Resistance exercise reduces liver fat and its mediators in non-alcoholic fatty liver disease independent of weight loss. Gut. 2011 Sep;60(9):1278-83. doi: 10.1136/gut.2011.242073. Epub 2011 Jun 27.
PubMed 21708823Fealy CE, Haus JM, Solomon TP, Pagadala M, Flask CA, McCullough AJ, Kirwan JP. Short-term exercise reduces markers of hepatocyte apoptosis in nonalcoholic fatty liver disease. J Appl Physiol (1985). 2012 Jul;113(1):1-6. doi: 10.1152/japplphysiol.00127.2012. Epub 2012 May 10.
PubMed 22582214Jin YJ, Kim KM, Hwang S, Lee SG, Ha TY, Song GW, Jung DH, Kim KH, Yu E, Shim JH, Lim YS, Lee HC, Chung YH, Lee Y, Suh DJ. Exercise and diet modification in non-obese non-alcoholic fatty liver disease: analysis of biopsies of living liver donors. J Gastroenterol Hepatol. 2012 Aug;27(8):1341-7. doi: 10.1111/j.1440-1746.2012.07165.x.
PubMed 22554085Oh S, Tanaka K, Warabi E, Shoda J. Exercise reduces inflammation and oxidative stress in obesity-related liver diseases. Med Sci Sports Exerc. 2013 Dec;45(12):2214-22. doi: 10.1249/MSS.0b013e31829afc33.
PubMed 23698242Zelber-Sagi S, Buch A, Yeshua H, Vaisman N, Webb M, Harari G, Kis O, Fliss-Isakov N, Izkhakov E, Halpern Z, Santo E, Oren R, Shibolet O. Effect of resistance training on non-alcoholic fatty-liver disease a randomized-clinical trial. World J Gastroenterol. 2014 Apr 21;20(15):4382-92. doi: 10.3748/wjg.v20.i15.4382.
PubMed 24764677Bacchi E, Negri C, Targher G, Faccioli N, Lanza M, Zoppini G, Zanolin E, Schena F, Bonora E, Moghetti P. Both resistance training and aerobic training reduce hepatic fat content in type 2 diabetic subjects with nonalcoholic fatty liver disease (the RAED2 Randomized Trial). Hepatology. 2013 Oct;58(4):1287-95. doi: 10.1002/hep.26393. Epub 2013 Aug 22.
PubMed 23504926
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Type of Exercise on Hepatic Fat Content and Metabolic Profiles in Non-alcoholic Fatty Liver Disease: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02679417
- Acronym / sponsor ID
- 183/2558(EC1)
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Aminotransferase, Fibrosis, liver, Anthropometry, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Feb 2016 (estimated)
- 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.
The type of physical activity such as, aerobic or resistant exercise required to reduce liver fat content in patient with non-alcoholic fatty liver disease (NAFLD) remains unclear. The purpose of this study is to determine whether aerobic exercise should provide improvement of hepatic fat content and inflammation as well as metabolic profiles and anthropometric parameters better than resistant exercise.
Detailed description
Increasing prevalence of overweight and obese worldwide, non-alcoholic fatty liver disease (NAFLD) is commonly diagnosed in daily clinical practice. Weight reduction has been the only strategy established thus far to reduce hepatic lipid levels. Thus, dietary restriction and exercise focusing on weight reduction is recommended as the cornerstone for managing NAFLD. Recent reports have indicated that increased exercise greatly reduces hepatic fat accumulation and inflammation and the related oxidative stress levels outweigh those achieved by dietary restriction alone. Clear guidelines for such a "lifestyle physical activity" for NAFLD management are currently lacking. The type of physical activity such as, aerobic or resistant exercise required to reduce liver fat content remains unclear.The purpose of this study is to determine whether aerobic exercise should provide improvement of hepatic fat content and inflammation as well as metabolic profiles and anthropometric parameters better than resistant exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise | Active comparator | Behavioral: exerciseEach participant reach a minimum of 50 minutes of some form of aerobic exercise including running on a treadmill 5 to 7 days per week for 12 weeks under the supervision of fitness center trainers. |
| resistant exercise | Active comparator | Behavioral: exerciseEach participant reach a minimum of 50 minutes of some form of strength training involving repetitions of a resistance training exercise for each major muscle group at an intensity for at least 60% of a one-repetition max, 5 to 7 days per week for 12 weeks under the supervision of fitness center trainers. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Siriraj medical personals
- Ultrasonography show liver steatosis by using ultrasound criteria
- Transient elastography by using the controlled attenuation parameter show moderate degree of fatty accumulation in the liver
- History of alcohol consumption in male <20 g/d, female <10 g/d
Key exclusion criteria (4 listed)
- Liver disease of other etiology
- Medications that caused fatty accumulation in the liver
- Treated with vitamin E or antidiabetic agents
- Cardiopulmonary diseases or orthopedic conditions that are contraindicated for exercise
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 |
|---|---|---|
| exercise12 weeks of aerobic or resistant exercise | Behavioural | aerobic exercise, resistant exercise |
Primary outcome
Hepatic fat content as assessed by the controlled attenuation parameter.
Time frame: 12 weeks
Hepatic fat content will be assessed with the controlled attenuation parameter (CAP) at baseline and the end of 12 weeks. The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements.
5 secondary outcomes
Hepatic inflammation as assessed by serum levels of aspartate aminotransferase, alanine aminotransferase, ferritin and c-reactive protein.
Time frame: 12 weeks
Liver fibrosis as assessed by vibration-controlled transient elastography.
Time frame: 12 weeks
Metabolic profiles assessed with the measurement of lipid profiles, plasma glucose, insulin and oral glucose tolerance test.
Time frame: 12 weeks
Anthropometry and bioelectrical impedance assessed by a bioelectrical fat analyzer.
Time frame: 12 weeks
Cardiorespiratory fitness as assessed with maximal oxygen uptake under treadmill test.
Time frame: 12 weeks
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 14 Sep 2016.
- Background: PubMed 22488764Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.
- Background: PubMed 21623852Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30.
- Background: PubMed 14609874Beymer C, Kowdley KV, Larson A, Edmonson P, Dellinger EP, Flum DR. Prevalence and predictors of asymptomatic liver disease in patients undergoing gastric bypass surgery. Arch Surg. 2003 Nov;138(11):1240-4. doi: 10.1001/archsurg.138.11.1240.
- Background: PubMed 18384521Leite NC, Salles GF, Araujo AL, Villela-Nogueira CA, Cardoso CR. Prevalence and associated factors of non-alcoholic fatty liver disease in patients with type-2 diabetes mellitus. Liver Int. 2009 Jan;29(1):113-9. doi: 10.1111/j.1478-3231.2008.01718.x. Epub 2008 Apr 1.
- Background: PubMed 11117562Assy N, Kaita K, Mymin D, Levy C, Rosser B, Minuk G. Fatty infiltration of liver in hyperlipidemic patients. Dig Dis Sci. 2000 Oct;45(10):1929-34. doi: 10.1023/a:1005661516165.
- Background: PubMed 21039302Musso G, Gambino R, Cassader M, Pagano G. Meta-analysis: natural history of non-alcoholic fatty liver disease (NAFLD) and diagnostic accuracy of non-invasive tests for liver disease severity. Ann Med. 2011 Dec;43(8):617-49. doi: 10.3109/07853890.2010.518623. Epub 2010 Nov 2.
- Background: PubMed 19148800Hashimoto E, Yatsuji S, Tobari M, Taniai M, Torii N, Tokushige K, Shiratori K. Hepatocellular carcinoma in patients with nonalcoholic steatohepatitis. J Gastroenterol. 2009;44 Suppl 19:89-95. doi: 10.1007/s00535-008-2262-x. Epub 2009 Jan 16.
- Background: PubMed 19827166Promrat K, Kleiner DE, Niemeier HM, Jackvony E, Kearns M, Wands JR, Fava JL, Wing RR. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Hepatology. 2010 Jan;51(1):121-9. doi: 10.1002/hep.23276.
- Background: PubMed 22213436Sullivan S, Kirk EP, Mittendorfer B, Patterson BW, Klein S. Randomized trial of exercise effect on intrahepatic triglyceride content and lipid kinetics in nonalcoholic fatty liver disease. Hepatology. 2012 Jun;55(6):1738-45. doi: 10.1002/hep.25548. Epub 2012 Apr 25.
- Background: PubMed 21708823Hallsworth K, Fattakhova G, Hollingsworth KG, Thoma C, Moore S, Taylor R, Day CP, Trenell MI. Resistance exercise reduces liver fat and its mediators in non-alcoholic fatty liver disease independent of weight loss. Gut. 2011 Sep;60(9):1278-83. doi: 10.1136/gut.2011.242073. Epub 2011 Jun 27.
- Background: PubMed 22582214Fealy CE, Haus JM, Solomon TP, Pagadala M, Flask CA, McCullough AJ, Kirwan JP. Short-term exercise reduces markers of hepatocyte apoptosis in nonalcoholic fatty liver disease. J Appl Physiol (1985). 2012 Jul;113(1):1-6. doi: 10.1152/japplphysiol.00127.2012. Epub 2012 May 10.
- Background: PubMed 22554085Jin YJ, Kim KM, Hwang S, Lee SG, Ha TY, Song GW, Jung DH, Kim KH, Yu E, Shim JH, Lim YS, Lee HC, Chung YH, Lee Y, Suh DJ. Exercise and diet modification in non-obese non-alcoholic fatty liver disease: analysis of biopsies of living liver donors. J Gastroenterol Hepatol. 2012 Aug;27(8):1341-7. doi: 10.1111/j.1440-1746.2012.07165.x.
- 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.
Phunchai Charatcharoenwitthaya, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Non-alcoholic Fatty Liver Disease, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 4 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
Hepatic fat content as assessed by the controlled attenuation parameter. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679417, which also lists 16 linked publications.
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 14 Sep 2016.