The Effects of Type of Exercise in Non-alcoholic Fatty Liver Disease

NCT ID: NCT02679417

Last Updated: 2016-09-14

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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

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Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aerobic exercise

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.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type BEHAVIORAL

12 weeks of aerobic or resistant exercise

resistant exercise

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.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type BEHAVIORAL

12 weeks of aerobic or resistant exercise

Interventions

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exercise

12 weeks of aerobic or resistant exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Phunchai Charatcharoenwitthaya

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Phunchai Charatcharoenwitthaya, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 22488764 (View on PubMed)

Vernon 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.

Reference Type BACKGROUND
PMID: 21623852 (View on PubMed)

Beymer 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.

Reference Type BACKGROUND
PMID: 14609874 (View on PubMed)

Leite 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.

Reference Type BACKGROUND
PMID: 18384521 (View on PubMed)

Assy 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.

Reference Type BACKGROUND
PMID: 11117562 (View on PubMed)

Musso 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.

Reference Type BACKGROUND
PMID: 21039302 (View on PubMed)

Hashimoto 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.

Reference Type BACKGROUND
PMID: 19148800 (View on PubMed)

Promrat 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.

Reference Type BACKGROUND
PMID: 19827166 (View on PubMed)

Sullivan 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.

Reference Type BACKGROUND
PMID: 22213436 (View on PubMed)

Hallsworth 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.

Reference Type BACKGROUND
PMID: 21708823 (View on PubMed)

Fealy 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.

Reference Type BACKGROUND
PMID: 22582214 (View on PubMed)

Jin 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.

Reference Type BACKGROUND
PMID: 22554085 (View on PubMed)

Oh 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.

Reference Type BACKGROUND
PMID: 23698242 (View on PubMed)

Zelber-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.

Reference Type BACKGROUND
PMID: 24764677 (View on PubMed)

Bacchi 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.

Reference Type BACKGROUND
PMID: 23504926 (View on PubMed)

Charatcharoenwitthaya P, Kuljiratitikal K, Aksornchanya O, Chaiyasoot K, Bandidniyamanon W, Charatcharoenwitthaya N. Moderate-Intensity Aerobic vs Resistance Exercise and Dietary Modification in Patients With Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. Clin Transl Gastroenterol. 2021 Mar;12(3):e00316. doi: 10.14309/ctg.0000000000000316.

Reference Type DERIVED
PMID: 33939383 (View on PubMed)

Other Identifiers

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183/2558(EC1)

Identifier Type: -

Identifier Source: org_study_id

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