Prevention of NAFLD and CVD Through Lifestyle Intervention

Официальное название

Cardiovascular Diseases (CVD) and Nonalcoholic Fatty Liver Diseases (NAFLD) Among Gallstone and Cholecystectomy Patients and the Impact of a Novel Diet and Muscle Training Program

Обзор

Prevention of non-alcoholic fatty liver disease (NAFLD) and cardiovascular disease (CVD) through lifestyle intervention (MAUCO+) is a clinical trial that aims to improve sarcopenia, aerobic capacity, body composition, and lipid profile, insulin resistance, cardiovascular risk, NAFLD, and maintain a healthier lifestyle. Through the implementation of physical activity and nutritional programs.

Подробное описание

BACKGROUND. Gallstone disease (GSD), including gallstones and cholecystectomy, is a common digestive disease worldwide, and Chile has one of the highest reported rates of gallstone prevalence. GSD, in particular cholecystectomy, has been associated with nonalcoholic fatty liver disease (NAFLD). In previous studies, investigators confirmed the association of cholecystectomy with a higher risk of NAFLD only in men. Additionally, reasearchers found a higher cardiovascular event risk in 3 years for male gallstone carriers. Investigators aim to step forward toward translational research by evaluating the effectiveness of a risk-reduction strategy customized to our population.

STUDY GOALS. To evaluate a metabolic risk reduction strategy based on: 1. A Physical exercise trial to increase muscle mass and strength, and 2. A nutritional intervention based on an anti-inflammatory diet, sleep hygiene, and prolonged fasting periods.

METHODS. Intensive Lifestyle Intervention, Randomized Controlled Trial: 300 participants will be randomly allocated to control (n=150) or an experimental group (n=150). The control group will receive standard prevention recommendations, personalized advice, educational material regarding lifestyle and metabolic diseases, and follow-up evaluation of physical activity, physical condition, anthropometry, diet, and sleep habits. The intervention group will receive, tailored to each participant: 3.1 An Exercise Program consisting of directly supervised and home-based telehealth sessions emphasizing muscle building, and 3.2. A Nutritional plus Program based on a diet rich in anti-inflammatory components and legumes, low in fat and refined carbohydrates, controlled energy according to BMI, extended nocturnal fasting periods, and healthy sleep habits. The programs will have a 6-month intensive phase of bi-weekly directly supervised exercise sessions in a municipality gym and a weekly telehealth session, followed by six months of telephone support and bi-monthly direct supervision to reinforce adherence and early identification of risk factors for abandonment. Intervention outcomes measured at baseline and years 1 and 2 are changes in non-invasive serum and ultrasound-based biomarkers of NAFLD; improvement in sarcopenia, aerobic capacity, body composition, lipid profile, insulin resistance, and cardiovascular risk; among overweight participants, permanent loss of at least 5% body weight; the decrease of depression symptoms, improvement of quality of life scores, and maintenance of a healthier lifestyle.

EXPECTED RESULTS: is expected that a 12-month intervention of a personalized physical activity program together with a metabolic protective diet will improve markers of metabolic syndrome and NAFLD and decrease CVD risk scores in all participants who adhere to more than 50% of both interventions, with a clear dose-response effect.

Вмешательства

• Другое Physical exercise and dietary intervention for NAFLD
  Investigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet.

Первичные конечные точки

• Presence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later. [Срок оценки: 36 months]

Вторичные конечные точки (12)

• Framingham Cardiovascular risk score [Срок оценки: 36 months]
• HDL cholesterol (mg/dL) [Срок оценки: 36 months]
• Triglycerides (mg/dL) [Срок оценки: 36 months]
• Glycemia (mg/dL) [Срок оценки: 36 months]
• Insulin (uU/mL) [Срок оценки: 36 months]
• HBA1c [Срок оценки: 36 months]
• usPCR (mg/L) [Срок оценки: 36 months]
• AST:ALT ratio [Срок оценки: 36 months]
• Total cholesterol (mg/dL) [Срок оценки: 36 months]
• Platelets (#cells/uL) [Срок оценки: 36 months]
• HOMA-IR [Срок оценки: 36 months]
• Total Bilirrubin (mg/dL) [Срок оценки: 36 months]

Критерии участия

Критерии включения

• With and without gallstones disease
• With various degrees of NAFLD (none too severe)

Критерии исключения

• Any significant comorbidity or physical limitation to undergo resistance exercise program
• Use of medications that alter muscle mass (e.g., corticosteroids)
• History of hepatitis B or C
• Use of hepatotoxic drugs

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Чили · 1 центр

• Centro MAUCO+ — Molina

Публикации

• Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012 Apr;6(2):172-87. doi: 10.5009/gnl.2012.6.2.172. Epub 2012 Apr 17. PMID 22570746
• Latorre S G, Ivanovic-Zuvic S D, Corsi S O, Valdivia C G, Margozzini M P, Olea O R, Chianale B J, Miquel P JF. [Coverage of the gallbladder cancer prevention strategy in Chile: results from the 2009-2010 National Health Survey]. Rev Med Chil. 2015 Feb;143(2):158-67. doi: 10.4067/S0034-98872015000200002. Spanish. PMID 25860357
• Bertran E, Heise K, Andia ME, Ferreccio C. Gallbladder cancer: incidence and survival in a high-risk area of Chile. Int J Cancer. 2010 Nov 15;127(10):2446-54. doi: 10.1002/ijc.25421. PMID 20473911
• Hundal R, Shaffer EA. Gallbladder cancer: epidemiology and outcome. Clin Epidemiol. 2014 Mar 7;6:99-109. doi: 10.2147/CLEP.S37357. eCollection 2014. PMID 24634588
• Lammert F, Gurusamy K, Ko CW, Miquel JF, Mendez-Sanchez N, Portincasa P, van Erpecum KJ, van Laarhoven CJ, Wang DQ. Gallstones. Nat Rev Dis Primers. 2016 Apr 28;2:16024. doi: 10.1038/nrdp.2016.24. PMID 27121416
• Buch S, Schafmayer C, Volzke H, Becker C, Franke A, von Eller-Eberstein H, Kluck C, Bassmann I, Brosch M, Lammert F, Miquel JF, Nervi F, Wittig M, Rosskopf D, Timm B, Holl C, Seeger M, ElSharawy A, Lu T, Egberts J, Fandrich F, Folsch UR, Krawczak M, Schreiber S, Nurnberg P, Tepel J, Hampe J. A genome-wide association scan identifies the hepatic cholesterol transporter ABCG8 as a susceptibility fac PMID 17632509
• Bustos BI, Perez-Palma E, Buch S, Azocar L, Riveras E, Ugarte GD, Toliat M, Nurnberg P, Lieb W, Franke A, Hinz S, Burmeister G, von Schonfels W, Schafmayer C, Volzke H, Volker U, Homuth G, Lerch MM, Santos JL, Puschel K, Bambs C, Roa JC, Gutierrez RA, Hampe J, De Ferrari GV, Miquel JF. Variants in ABCG8 and TRAF3 genes confer risk for gallstone disease in admixed Latinos with Mapuche Native Americ PMID 30692554
• Nervi F, Miquel JF, Alvarez M, Ferreccio C, Garcia-Zattera MJ, Gonzalez R, Perez-Ayuso RM, Rigotti A, Villarroel L. Gallbladder disease is associated with insulin resistance in a high risk Hispanic population. J Hepatol. 2006 Aug;45(2):299-305. doi: 10.1016/j.jhep.2006.01.026. Epub 2006 Feb 17. PMID 16516330

Идентификаторы

NCT: NCT05618626 · FN1212066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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