- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06334666
The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD.
The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With Metabolic-associated Steatotic Liver Disease: a Randomized-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The results of the health survey of the Thai population through physical examinations in the year 2022 found that among Thai people aged 18 and older, the prevalence of obesity (BMI ≥25 kg/m2) was 44.9% (40.3% in males and 49.2% in females), which has increased significantly over the past decades. This condition is a significant factor contributing to the rising incidence of nonalcoholic fatty liver disease (NAFLD) among the Thai population. NAFLD refers to fatty liver disease in individuals who consume alcohol in amounts less than 140 grams per week for females or less than 210 grams per week for males. Those with clinical features of metabolic dysfunction have been newly defined as having metabolic-associated steatotic liver disease (MASLD).
In this survey of 18,588 individuals, the prevalence of NAFLD was 19.7%, with rates of 20.9% in males and 18.6% in females. It was notably higher at 43.5% in individuals with abdominal obesity (metabolic syndrome) and 35.6% in individuals with diabetes. Factors such as age, sex, physical activity, smoking, and metabolic characteristics such as overweight or obesity, abdominal obesity, high triglyceride levels, diabetes, hypertension, and low HDL cholesterol levels are significantly associated with NAFLD.
MASLD, a type of fatty liver disease, is directly associated with insulin resistance, a key risk factor for cardiovascular diseases. Current treatment guidelines for MASLD have clear evidence that weight loss through dietary control and appropriate physical activity or exercise can reduce fat accumulation in the liver, inflammation, and fibrosis. Importantly, it also improves various metabolic parameters such as blood sugar and lipid levels, as well as the effectiveness of insulin.
The etiology of MASLD is related to behavioral and environmental factors, such as high-calorie diets combined with low physical activity and sedentary lifestyles. These factors promote insulin resistance, stimulating lipolysis and the movement of free fatty acids to various organs, including the liver. This leads to fat accumulation in the liver, insulin-resistant hepatic tissue, abnormal β-oxidation processes, oxidative stress, hepatic inflammation, increased stellate cell activation, and subsequent fibrosis, eventually increasing the risk of liver cirrhosis and hepatocellular carcinoma.
Genetic polymorphisms play a significant role in MASLD pathogenesis, with single nucleotide polymorphisms (SNPs) in the patatin like phospholipase domain containing-3 gene, particularly the rs738409 variant, being strongly associated with fat accumulation and fibrosis in the liver.
Furthermore, a systematic review and analysis of data from 12 studies involving 111,309 individuals found that the number of steps per day, particularly 8,800 steps per day, was associated with a significant reduction in the risk of overall mortality and cardiovascular diseases (CVD). Additionally, increasing physical activity was associated with a reduced risk of chronic liver disease overall and NAFLD specifically. Increasing physical activity by 2,500 steps per day was associated with a 38% reduction in chronic liver disease and a 47% reduction in NAFLD, regardless of obesity status.
This research aims to conduct a randomized study to provide advice to MASLD patients to modify their diet and wear pedometers to encourage changes in physical activity, with a goal of achieving at least 8,800 steps per day, compared to MASLD patients who only receive dietary advice and wear pedometers to record daily steps over a 24-week period.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Phunchai Charatcharoenwitthaya, MD
- Phone Number: 6624197282
- Email: phunchai@yahoo.com
Study Contact Backup
- Name: Phacharapon Kittiratanapinun, MD
- Phone Number: 66892077155
- Email: 167si120@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must be diagnosed with MASLD according to the diagnostic criteria of the A multi-society Delphi consensus statement on new fatty liver disease nomenclature 2023, with evidence of hepatic steatosis and alcohol consumption of less than 140 grams per week for females or less than 210 grams per week for males, along with at least one of the clinical characteristics of metabolic syndrome.
- Participants must be at least 18 years old at the time of enrollment.
- Patients must consent to blood testing for the identification of the patatin like phospholipase domain containing-3 gene polymorphism.
Exclusion Criteria:
- Individuals who engage in regular exercise for at least 20 minutes per day, at least 3 days per week.
- Individuals who have regular physical activity with walking exceeding 3000 steps per day before participating in the study.
- Individuals diagnosed with other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, Wilson's disease, liver cancer, hemochromatosis, liver cirrhosis, or others.
- Individuals diagnosed with diseases that may affect non-alcoholic fatty liver disease, such as HIV, various chronic inflammatory diseases, or connective tissue disorders.
- Individuals taking medications known to promote fatty liver disease, including amiodarone, steroids, methotrexate, hormonal medications, or immunosuppressants.
- Individuals who have previously taken medications known to impact fatty liver disease, including vitamin E, pioglitazone, Glucagon-like peptide-1 agonists, SGLT2 inhibitors.
- Participants intending to join weight loss programs or undergo bariatric surgery for obesity treatment.
- Individuals with cirrhosis.
- Individuals diagnosed with liver cancer.
- Individuals with severe chronic diseases still exhibiting symptoms during physical activity that may exacerbate the disease, such as coronary artery disease, chronic obstructive pulmonary disease, or severe osteoarthritis.
- Patients with contraindications for undergoing MRI examinations, such as claustrophobia or having body implants or materials that are incompatible with MRI scanning.
- Women who are pregnant.
- Individuals who do not provide formal consent to participate in the research project.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Comparator: Encourage using pedometer group.
MASLD patient who received pedometer recording and was encouraged to use actively.
|
MASLD patient used pedometer recording actively with encourage by care provider or investigator
|
No Intervention: Placebo comparator: Discourage using pedometer group
MASLD patient who received pedometer recording but without encouraged to use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the changes in hepatic fat accumulation assessed by MRI-PDFF between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior.
Time Frame: 24 weeks
|
To compare the changes in hepatic fat accumulation assessed by magnetic resonance imaging proton-density fat fraction (MRI-PDFF) between the MASLD patient group wearing pedometers to promote achieving at least 8,800 steps per day, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare changes in metabolic parameters between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments.
Time Frame: 24 weeks
|
To compare changes in various metabolic parameters(e.g.
weight in kilograms, height in meters, blood sugar levels such as FBS in milligrams per deciliter or HbA1C in percentage , and blood lipid profiles such as total cholesteral in milligrams per deciliter) between the MASLD patient group wearing pedometers to promote achieving at least 8,800 steps per day, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments.
|
24 weeks
|
To study the impact of genes on changes in hepatic fat accumulation between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior.
Time Frame: 24 weeks
|
To study the impact of the patatin like phospholipase domain containing-3 rs738409 G alleles on changes in hepatic fat accumulation assessed by MRI-PDFF between the MASLD patient group wearing pedometers to promote achieving at least 8,800 steps per day, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Phunchai Charatcharoenwitthaya, MD, Faculty of Medicine Siriraj Hospital
Publications and helpful links
General Publications
- Karlas T, Petroff D, Sasso M, Fan JG, Mi YQ, de Ledinghen V, Kumar M, Lupsor-Platon M, Han KH, Cardoso AC, Ferraioli G, Chan WK, Wong VW, Myers RP, Chayama K, Friedrich-Rust M, Beaugrand M, Shen F, Hiriart JB, Sarin SK, Badea R, Jung KS, Marcellin P, Filice C, Mahadeva S, Wong GL, Crotty P, Masaki K, Bojunga J, Bedossa P, Keim V, Wiegand J. Individual patient data meta-analysis of controlled attenuation parameter (CAP) technology for assessing steatosis. J Hepatol. 2017 May;66(5):1022-1030. doi: 10.1016/j.jhep.2016.12.022. Epub 2016 Dec 28.
- Hernaez R, Lazo M, Bonekamp S, Kamel I, Brancati FL, Guallar E, Clark JM. Diagnostic accuracy and reliability of ultrasonography for the detection of fatty liver: a meta-analysis. Hepatology. 2011 Sep 2;54(3):1082-1090. doi: 10.1002/hep.24452.
- Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, Abdelmalek MF, Caldwell S, Barb D, Kleiner DE, Loomba R. AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023 May 1;77(5):1797-1835. doi: 10.1097/HEP.0000000000000323. Epub 2023 Mar 17. No abstract available.
- Romero-Gomez M, Zelber-Sagi S, Trenell M. Treatment of NAFLD with diet, physical activity and exercise. J Hepatol. 2017 Oct;67(4):829-846. doi: 10.1016/j.jhep.2017.05.016. Epub 2017 May 23.
- Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
- Ekstedt M, Nasr P, Kechagias S. Natural History of NAFLD/NASH. Curr Hepatol Rep. 2017;16(4):391-397. doi: 10.1007/s11901-017-0378-2. Epub 2017 Nov 13.
- Engin A. The Definition and Prevalence of Obesity and Metabolic Syndrome. Adv Exp Med Biol. 2017;960:1-17. doi: 10.1007/978-3-319-48382-5_1.
- Goodpaster BH, Katsiaras A, Kelley DE. Enhanced fat oxidation through physical activity is associated with improvements in insulin sensitivity in obesity. Diabetes. 2003 Sep;52(9):2191-7. doi: 10.2337/diabetes.52.9.2191.
- Jeon CY, Lokken RP, Hu FB, van Dam RM. Physical activity of moderate intensity and risk of type 2 diabetes: a systematic review. Diabetes Care. 2007 Mar;30(3):744-52. doi: 10.2337/dc06-1842.
- White T, Westgate K, Wareham NJ, Brage S. Estimation of Physical Activity Energy Expenditure during Free-Living from Wrist Accelerometry in UK Adults. PLoS One. 2016 Dec 9;11(12):e0167472. doi: 10.1371/journal.pone.0167472. eCollection 2016.
- LaMonte MJ, Lewis CE, Buchner DM, Evenson KR, Rillamas-Sun E, Di C, Lee IM, Bellettiere J, Stefanick ML, Eaton CB, Howard BV, Bird C, LaCroix AZ. Both Light Intensity and Moderate-to-Vigorous Physical Activity Measured by Accelerometry Are Favorably Associated With Cardiometabolic Risk Factors in Older Women: The Objective Physical Activity and Cardiovascular Health (OPACH) Study. J Am Heart Assoc. 2017 Oct 17;6(10):e007064. doi: 10.1161/JAHA.117.007064.
- Kim D, Murag S, Cholankeril G, Cheung A, Harrison SA, Younossi ZM, Ahmed A. Physical Activity, Measured Objectively, Is Associated With Lower Mortality in Patients With Nonalcoholic Fatty Liver Disease. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1240-1247.e5. doi: 10.1016/j.cgh.2020.07.023. Epub 2020 Jul 16.
- Saint-Maurice PF, Troiano RP, Berrigan D, Kraus WE, Matthews CE. Volume of Light Versus Moderate-to-Vigorous Physical Activity: Similar Benefits for All-Cause Mortality? J Am Heart Assoc. 2018 Apr 2;7(7):e008815. doi: 10.1161/JAHA.118.008815. Erratum In: J Am Heart Assoc. 2018 Dec 4;7(23):e03714.
- Bird SR, Hawley JA. Update on the effects of physical activity on insulin sensitivity in humans. BMJ Open Sport Exerc Med. 2017 Mar 1;2(1):e000143. doi: 10.1136/bmjsem-2016-000143. eCollection 2016.
- Kwak MS, Kim D, Chung GE, Kim W, Kim JS. The preventive effect of sustained physical activity on incident nonalcoholic fatty liver disease. Liver Int. 2017 Jun;37(6):919-926. doi: 10.1111/liv.13332. Epub 2016 Dec 24.
- Kistler KD, Brunt EM, Clark JM, Diehl AM, Sallis JF, Schwimmer JB; NASH CRN Research Group. Physical activity recommendations, exercise intensity, and histological severity of nonalcoholic fatty liver disease. Am J Gastroenterol. 2011 Mar;106(3):460-8; quiz 469. doi: 10.1038/ajg.2010.488. Epub 2011 Jan 4.
- Asada F, Nomura T, Hosui A, Kubota M. Influence of increased physical activity without body weight loss on hepatic inflammation in patients with nonalcoholic fatty liver disease. Environ Health Prev Med. 2020 Jun 10;25(1):18. doi: 10.1186/s12199-020-00857-6.
- Stine JG, Munaganuru N, Barnard A, Wang JL, Kaulback K, Argo CK, Singh S, Fowler KJ, Sirlin CB, Loomba R. Change in MRI-PDFF and Histologic Response in Patients With Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2274-2283.e5. doi: 10.1016/j.cgh.2020.08.061. Epub 2020 Aug 31.
- Shen J, Wong GL, Chan HL, Chan RS, Chan HY, Chu WC, Cheung BH, Yeung DK, Li LS, Sea MM, Woo J, Wong VW. PNPLA3 gene polymorphism and response to lifestyle modification in patients with nonalcoholic fatty liver disease. J Gastroenterol Hepatol. 2015 Jan;30(1):139-46. doi: 10.1111/jgh.12656.
- Koutoukidis DA, Koshiaris C, Henry JA, Noreik M, Morris E, Manoharan I, Tudor K, Bodenham E, Dunnigan A, Jebb SA, Aveyard P. The effect of the magnitude of weight loss on non-alcoholic fatty liver disease: A systematic review and meta-analysis. Metabolism. 2021 Feb;115:154455. doi: 10.1016/j.metabol.2020.154455. Epub 2020 Nov 29.
- Sheka AC, Adeyi O, Thompson J, Hameed B, Crawford PA, Ikramuddin S. Nonalcoholic Steatohepatitis: A Review. JAMA. 2020 Mar 24;323(12):1175-1183. doi: 10.1001/jama.2020.2298. Erratum In: JAMA. 2020 Apr 28;323(16):1619.
- Hallsworth K, Thoma C, Moore S, Ploetz T, Anstee QM, Taylor R, Day CP, Trenell MI. Non-alcoholic fatty liver disease is associated with higher levels of objectively measured sedentary behaviour and lower levels of physical activity than matched healthy controls. Frontline Gastroenterol. 2015 Jan;6(1):44-51. doi: 10.1136/flgastro-2014-100432. Epub 2014 Jun 30.
- Koolhaas CM, van Rooij FJ, Cepeda M, Tiemeier H, Franco OH, Schoufour JD. Physical activity derived from questionnaires and wrist-worn accelerometers: comparability and the role of demographic, lifestyle, and health factors among a population-based sample of older adults. Clin Epidemiol. 2017 Dec 18;10:1-16. doi: 10.2147/CLEP.S147613. eCollection 2018.
- Gerber L, Otgonsuren M, Mishra A, Escheik C, Birerdinc A, Stepanova M, Younossi ZM. Non-alcoholic fatty liver disease (NAFLD) is associated with low level of physical activity: a population-based study. Aliment Pharmacol Ther. 2012 Oct;36(8):772-81. doi: 10.1111/apt.12038. Epub 2012 Sep 8.
- Joo JH, Kim HJ, Park EC, Jang SI. Association between sitting time and non-alcoholic fatty live disease in South Korean population: a cross-sectional study. Lipids Health Dis. 2020 Sep 23;19(1):212. doi: 10.1186/s12944-020-01385-6.
- St George A, Bauman A, Johnston A, Farrell G, Chey T, George J. Independent effects of physical activity in patients with nonalcoholic fatty liver disease. Hepatology. 2009 Jul;50(1):68-76. doi: 10.1002/hep.22940.
- Zelber-Sagi S, Nitzan-Kaluski D, Goldsmith R, Webb M, Zvibel I, Goldiner I, Blendis L, Halpern Z, Oren R. Role of leisure-time physical activity in nonalcoholic fatty liver disease: a population-based study. Hepatology. 2008 Dec;48(6):1791-8. doi: 10.1002/hep.22525.
- Mansour-Ghanaei R, Mansour-Ghanaei F, Naghipour M, Joukar F. The Lifestyle Characteristics in Non-Alcoholic Fatty Liver Disease in the PERSIAN Guilan Cohort Study. Open Access Maced J Med Sci. 2019 Sep 14;7(19):3313-3318. doi: 10.3889/oamjms.2019.647. eCollection 2019 Oct 15.
- European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; Clinical Practice Guideline Panel; Chair:; EASL Governing Board representative:; Panel members:. EASL Clinical Practice Guidelines on non-invasive tests for evaluation of liver disease severity and prognosis - 2021 update. J Hepatol. 2021 Sep;75(3):659-689. doi: 10.1016/j.jhep.2021.05.025. Epub 2021 Jun 21.
- Maximos M, Bril F, Portillo Sanchez P, Lomonaco R, Orsak B, Biernacki D, Suman A, Weber M, Cusi K. The role of liver fat and insulin resistance as determinants of plasma aminotransferase elevation in nonalcoholic fatty liver disease. Hepatology. 2015 Jan;61(1):153-60. doi: 10.1002/hep.27395. Epub 2014 Nov 25.
- Anstee QM, Day CP. The Genetics of Nonalcoholic Fatty Liver Disease: Spotlight on PNPLA3 and TM6SF2. Semin Liver Dis. 2015 Aug;35(3):270-90. doi: 10.1055/s-0035-1562947. Epub 2015 Sep 17.
- Krawczyk M, Rau M, Schattenberg JM, Bantel H, Pathil A, Demir M, Kluwe J, Boettler T, Lammert F, Geier A; NAFLD Clinical Study Group. Combined effects of the PNPLA3 rs738409, TM6SF2 rs58542926, and MBOAT7 rs641738 variants on NAFLD severity: a multicenter biopsy-based study. J Lipid Res. 2017 Jan;58(1):247-255. doi: 10.1194/jlr.P067454. Epub 2016 Nov 11.
- Akuta N, Kawamura Y, Arase Y, Suzuki F, Sezaki H, Hosaka T, Kobayashi M, Kobayashi M, Saitoh S, Suzuki Y, Ikeda K, Kumada H. Relationships between Genetic Variations of PNPLA3, TM6SF2 and Histological Features of Nonalcoholic Fatty Liver Disease in Japan. Gut Liver. 2016 May 23;10(3):437-45. doi: 10.5009/gnl15163.
- Romeo S, Kozlitina J, Xing C, Pertsemlidis A, Cox D, Pennacchio LA, Boerwinkle E, Cohen JC, Hobbs HH. Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet. 2008 Dec;40(12):1461-5. doi: 10.1038/ng.257. Epub 2008 Sep 25.
- Trepo E, Romeo S, Zucman-Rossi J, Nahon P. PNPLA3 gene in liver diseases. J Hepatol. 2016 Aug;65(2):399-412. doi: 10.1016/j.jhep.2016.03.011. Epub 2016 Mar 30.
- Boeckmans J, Gatzios A, Schattenberg JM, Koek GH, Rodrigues RM, Vanhaecke T. PNPLA3 I148M and response to treatment for hepatic steatosis: A systematic review. Liver Int. 2023 May;43(5):975-988. doi: 10.1111/liv.15533. Epub 2023 Feb 16.
- Stens NA, Bakker EA, Manas A, Buffart LM, Ortega FB, Lee DC, Thompson PD, Thijssen DHJ, Eijsvogels TMH. Relationship of Daily Step Counts to All-Cause Mortality and Cardiovascular Events. J Am Coll Cardiol. 2023 Oct 10;82(15):1483-1494. doi: 10.1016/j.jacc.2023.07.029. Epub 2023 Sep 6.
- Schneider CV, Zandvakili I, Thaiss CA, Schneider KM. Physical activity is associated with reduced risk of liver disease in the prospective UK Biobank cohort. JHEP Rep. 2021 Mar 2;3(3):100263. doi: 10.1016/j.jhepr.2021.100263. eCollection 2021 Jun.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SI 172/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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