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

NCT02679417 | Completed

• 1 other identifier: 183/2558(EC1)
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Aminotransferase; Fibrosis, liver; Anthropometry; Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (5)

• Hepatic inflammation as assessed by serum levels of aspartate aminotransferase, alanine aminotransferase, ferritin and c-reactive protein.

  12 weeks

• Liver fibrosis as assessed by vibration-controlled transient elastography.

  12 weeks

• Metabolic profiles assessed with the measurement of lipid profiles, plasma glucose, insulin and oral glucose tolerance test.

  12 weeks

• Anthropometry and bioelectrical impedance assessed by a bioelectrical fat analyzer.

  12 weeks

• Cardiorespiratory fitness as assessed with maximal oxygen uptake under treadmill test.

  12 weeks

Study Arms (2)

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.

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.

Behavioral: exercise

Interventions

exercise BEHAVIORAL

12 weeks of aerobic or resistant exercise

aerobic exercise; resistant exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (16)

• 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.

  PMID: 22488764 BACKGROUND

• 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.

  PMID: 21623852 BACKGROUND

• 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.

  PMID: 14609874 BACKGROUND

• 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.

  PMID: 18384521 BACKGROUND

• 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.

  PMID: 11117562 BACKGROUND

• 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.

  PMID: 21039302 BACKGROUND

• 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.

  PMID: 19148800 BACKGROUND

• 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.

  PMID: 19827166 BACKGROUND

• 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.

  PMID: 22213436 BACKGROUND

• 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.

  PMID: 21708823 BACKGROUND

• 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.

  PMID: 22582214 BACKGROUND

• 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.

  PMID: 22554085 BACKGROUND

• 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.

  PMID: 23698242 BACKGROUND

• 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.

  PMID: 24764677 BACKGROUND

• 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.

  PMID: 23504926 BACKGROUND

• 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.

  PMID: 33939383 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Phunchai Charatcharoenwitthaya, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 10, 2016
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)