Non-Alcoholic Fatty Liver DiseaseMAUCO+NCT05618626
Prevention of NAFLD and CVD Through Lifestyle Intervention
A study testing Physical exercise and dietary intervention for NAFLD in people with Non-Alcoholic Fatty Liver Disease and Gallstone Disease, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Gallstone Disease
- What is being tested?
- Physical exercise and dietary intervention for NAFLD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChile
- Study dates
- 27 Sep 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- With and without gallstones disease
- With various degrees of NAFLD (none too severe)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Centro MAUCO+
Molina, Maule Region
Laura A Huidobro, MD, PhD, ahuidobro@ucm.cl
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Physical exercise and dietary intervention for NAFLD
- Keywords
- Anti-inflammatory diet, Lifestyle modification, Physical Activity
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Cholelithiasis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise and dietary intervention for NAFLDOther
Investigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet.
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise and dietary intervention for NAFLD | Experimental | The exercise program will consist of muscular strength and aerobic exercises; additionally, each session will start and end with low intensity warm-up and cool down periods. The program will be divided in months. Months 1-2, twice a week directly-supervised exercises group sessions, and 1 telehealth session. Months 3-6, once a week directly-supervised group session and twice a week home-based telehealth. Months 7-12, Monthly telephone support. Months 12, 24 and 36, All participants (control and intervention arms) will receive a full evaluation. In the dietary intervention, investigators proposed a diet rich in anti-inflammatory components, legumes and in dietary fiber. The baseline evaluation of nutritional condition includes: anthropometry, bioimpedance analysis, hepatobiliary ultrasound, Fibroscan,blood lipids, and a battery of metabolic markers and a diet survey, Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). Both interventions are performed in parallel. Receives: Other: Physical exercise and dietary intervention for NAFLD |
| Standard of care | No intervention | Participants in the control arm first have a baseline evaluation of the nutritional condition, with anthropometry evaluation, bioimpedance analysis, hepatobiliary ultrasound, Fibroscan, blood lipids, a battery of metabolic markers, and a diet survey, Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). After the evaluation period, participants received one counseling session, including written material, with advice to follow a healthy diet rich in fruits and vegetables, whole-grain foods, low in salt and sugars, and recommendations for an exercise plan of at least 30 minutes of aerobic exercise three times a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later.
It will be measured through the liver steatosis marker "Controlled Attenuation Parameter (CAP)" (dB/m).
Measured: 36 months
Secondary outcomes (17)
Framingham Cardiovascular risk score
It will be measured at baseline and 12 months.
Measured: 36 months
HDL cholesterol (mg/dL)
It will be measured at baseline and 12 months.
Measured: 36 months
Triglycerides (mg/dL)
It will be measured at baseline and 12 months.
Measured: 36 months
Glycemia (mg/dL)
It will be measured at baseline and 12 months.
Measured: 36 months
Insulin (uU/mL)
It will be measured at baseline and 12 months.
Measured: 36 months
HBA1c
It will be measured at baseline and 12 months.
Measured: 36 months
usPCR (mg/L)
It will be measured at baseline and 12 months.
Measured: 36 months
AST:ALT ratio
It will be measured at baseline and 12 months.
Measured: 36 months
Total cholesterol (mg/dL)
It will be measured at baseline and 12 months.
Measured: 36 months
Platelets (#cells/uL)
It will be measured at baseline and 12 months.
Measured: 36 months
HOMA-IR
It will be measured at baseline and 12 months.
Measured: 36 months
Total Bilirrubin (mg/dL)
It will be measured at baseline and 12 months.
Measured: 36 months
Alkaline phosphatase (UI/l)
It will be measured at baseline and 12 months.
Measured: 36 months
Glutamiz oxaloacetic transaminase (GOT) (UI/l)
It will be measured at baseline and 12 months.
Measured: 36 months
Glutamic pyruvic trasaminase (GPT) (UI/l)
It will be measured at baseline and 12 months.
Measured: 36 months
Gamma-glutamyl Transferase (GGT) (UI/l)
It will be measured at baseline and 12 months.
Measured: 36 months
Metabolic syndrome
To be diagnosed with metabolic syndrome it is necessary to meet 3 or more conditions. (abdominal obesity, high triglycerides, low HDL cholesterol, high blood pressure and high fasting glucose). Metabolic syndrome will be measure at baseline and 12 month.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start27 Sep 2021
- Primary completion28 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (101)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 Pontificia Universidad Catolica de ChileThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catterina Ferreccio, Pontificia Universidad Catolica de Chile
- Investigators
- Catterina Ferreccio, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618626
- Sponsor's protocol ID
- FN1212066
- Acronym
- MAUCO+
- Status last verified
- Nov 2024
- First submitted
- 17 Jun 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22570746Latorre 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.
PubMed 25860357Bertran 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.
PubMed 20473911Hundal R, Shaffer EA. Gallbladder cancer: epidemiology and outcome. Clin Epidemiol. 2014 Mar 7;6:99-109. doi: 10.2147/CLEP.S37357. eCollection 2014.
PubMed 24634588Lammert 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.
PubMed 27121416Buch 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 factor for human gallstone disease. Nat Genet. 2007 Aug;39(8):995-9. doi: 10.1038/ng2101. Epub 2007 Jul 15.
PubMed 17632509Bustos 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 American ancestry. Sci Rep. 2019 Jan 28;9(1):772. doi: 10.1038/s41598-018-35852-z.
PubMed 30692554Nervi 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.
PubMed 16516330Lin IC, Yang YW, Wu MF, Yeh YH, Liou JC, Lin YL, Chiang CH. The association of metabolic syndrome and its factors with gallstone disease. BMC Fam Pract. 2014 Jul 29;15:138. doi: 10.1186/1471-2296-15-138.
PubMed 25070766Shaffer EA. Epidemiology and risk factors for gallstone disease: has the paradigm changed in the 21st century? Curr Gastroenterol Rep. 2005 May;7(2):132-40. doi: 10.1007/s11894-005-0051-8.
PubMed 15802102Haas JT, Francque S, Staels B. Pathophysiology and Mechanisms of Nonalcoholic Fatty Liver Disease. Annu Rev Physiol. 2016;78:181-205. doi: 10.1146/annurev-physiol-021115-105331. Epub 2015 Nov 30.
PubMed 26667070Riquelme A, Arrese M, Soza A, Morales A, Baudrand R, Perez-Ayuso RM, Gonzalez R, Alvarez M, Hernandez V, Garcia-Zattera MJ, Otarola F, Medina B, Rigotti A, Miquel JF, Marshall G, Nervi F. Non-alcoholic fatty liver disease and its association with obesity, insulin resistance and increased serum levels of C-reactive protein in Hispanics. Liver Int. 2009 Jan;29(1):82-8. doi: 10.1111/j.1478-3231.2008.01823.x. Epub 2008 Jul 16.
PubMed 18647235Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.
PubMed 28930295Bellentani S. The epidemiology of non-alcoholic fatty liver disease. Liver Int. 2017 Jan;37 Suppl 1:81-84. doi: 10.1111/liv.13299.
PubMed 28052624Arrese M, Cortes V, Barrera F, Nervi F. Nonalcoholic fatty liver disease, cholesterol gallstones, and cholecystectomy: new insights on a complex relationship. Curr Opin Gastroenterol. 2018 Mar;34(2):90-96. doi: 10.1097/MOG.0000000000000416.
PubMed 29266009
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05618626
- Acronym / sponsor ID
- MAUCO+ / FN1212066
- Keywords
- Anti-inflammatory diet, Lifestyle modification, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 16 Nov 2022 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical exercise and dietary intervention for NAFLD | Experimental | Other: Physical exercise and dietary intervention for NAFLDThe exercise program will consist of muscular strength and aerobic exercises; additionally, each session will start and end with low intensity warm-up and cool down periods. The program will be divided in months. Months 1-2, twice a week directly-supervised exercises group sessions, and 1 telehealth session. Months 3-6, once a week directly-supervised group session and twice a week home-based telehealth. Months 7-12, Monthly telephone support. Months 12, 24 and 36, All participants (control and intervention arms) will receive a full evaluation. In the dietary intervention, investigators proposed a diet rich in anti-inflammatory components, legumes and in dietary fiber. The baseline evaluation of nutritional condition includes: anthropometry, bioimpedance analysis, hepatobiliary ultrasound, Fibroscan,blood lipids, and a battery of metabolic markers and a diet survey, Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). Both interventions are performed in parallel. |
| Standard of care | No intervention | –Participants in the control arm first have a baseline evaluation of the nutritional condition, with anthropometry evaluation, bioimpedance analysis, hepatobiliary ultrasound, Fibroscan, blood lipids, a battery of metabolic markers, and a diet survey, Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). After the evaluation period, participants received one counseling session, including written material, with advice to follow a healthy diet rich in fruits and vegetables, whole-grain foods, low in salt and sugars, and recommendations for an exercise plan of at least 30 minutes of aerobic exercise three times a week. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- With and without gallstones disease
- With various degrees of NAFLD (none too severe)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Physical exercise and dietary intervention for NAFLDInvestigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet. | Other | Physical exercise and dietary intervention for NAFLD |
Primary outcome
Presence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later.
Time frame: 36 months
It will be measured through the liver steatosis marker "Controlled Attenuation Parameter (CAP)" (dB/m).
17 secondary outcomes
Framingham Cardiovascular risk score
Time frame: 36 months
HDL cholesterol (mg/dL)
Time frame: 36 months
Triglycerides (mg/dL)
Time frame: 36 months
Glycemia (mg/dL)
Time frame: 36 months
Insulin (uU/mL)
Time frame: 36 months
HBA1c
Time frame: 36 months
usPCR (mg/L)
Time frame: 36 months
AST:ALT ratio
Time frame: 36 months
Total cholesterol (mg/dL)
Time frame: 36 months
Platelets (#cells/uL)
Time frame: 36 months
HOMA-IR
Time frame: 36 months
Total Bilirrubin (mg/dL)
Time frame: 36 months
Alkaline phosphatase (UI/l)
Time frame: 36 months
Glutamiz oxaloacetic transaminase (GOT) (UI/l)
Time frame: 36 months
Glutamic pyruvic trasaminase (GPT) (UI/l)
Time frame: 36 months
Gamma-glutamyl Transferase (GGT) (UI/l)
Time frame: 36 months
Metabolic syndrome
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 22570746Stinton 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.
- Background: PubMed 25860357Latorre 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.
- Background: PubMed 20473911Bertran 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.
- Background: PubMed 24634588Hundal R, Shaffer EA. Gallbladder cancer: epidemiology and outcome. Clin Epidemiol. 2014 Mar 7;6:99-109. doi: 10.2147/CLEP.S37357. eCollection 2014.
- Background: PubMed 27121416Lammert 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.
- Background: PubMed 17632509Buch 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 factor for human gallstone disease. Nat Genet. 2007 Aug;39(8):995-9. doi: 10.1038/ng2101. Epub 2007 Jul 15.
- Background: PubMed 30692554Bustos 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 American ancestry. Sci Rep. 2019 Jan 28;9(1):772. doi: 10.1038/s41598-018-35852-z.
- Background: PubMed 16516330Nervi 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.
- Background: PubMed 25070766Lin IC, Yang YW, Wu MF, Yeh YH, Liou JC, Lin YL, Chiang CH. The association of metabolic syndrome and its factors with gallstone disease. BMC Fam Pract. 2014 Jul 29;15:138. doi: 10.1186/1471-2296-15-138.
- Background: PubMed 15802102Shaffer EA. Epidemiology and risk factors for gallstone disease: has the paradigm changed in the 21st century? Curr Gastroenterol Rep. 2005 May;7(2):132-40. doi: 10.1007/s11894-005-0051-8.
- Background: PubMed 26667070Haas JT, Francque S, Staels B. Pathophysiology and Mechanisms of Nonalcoholic Fatty Liver Disease. Annu Rev Physiol. 2016;78:181-205. doi: 10.1146/annurev-physiol-021115-105331. Epub 2015 Nov 30.
- Background: PubMed 18647235Riquelme A, Arrese M, Soza A, Morales A, Baudrand R, Perez-Ayuso RM, Gonzalez R, Alvarez M, Hernandez V, Garcia-Zattera MJ, Otarola F, Medina B, Rigotti A, Miquel JF, Marshall G, Nervi F. Non-alcoholic fatty liver disease and its association with obesity, insulin resistance and increased serum levels of C-reactive protein in Hispanics. Liver Int. 2009 Jan;29(1):82-8. doi: 10.1111/j.1478-3231.2008.01823.x. Epub 2008 Jul 16.
- 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.
Catterina Ferreccio, MD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and dietary intervention for NAFLD in people with Non-Alcoholic Fatty Liver Disease and Gallstone Disease, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 2 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. 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 Chile. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura A Huidobro, PhD (+56 9 9219 6618, leahuidobro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later. (time frame: 36 months). 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 NCT05618626, which also lists 101 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 19 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.