Paso Program for Fatty Liver Disease
Recruiting in Palo Alto (17 mi)
Overseen byMaya Balakrishnan
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Baylor College of Medicine
Must not be taking: SGLT2 inhibitors, GLP-1 agonists
Disqualifiers: Advanced liver disease, Organ transplant, Heavy alcohol use, Active cancer, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to learn whether the Paso weight loss program is feasible for Mexican and Central American patients with fatty liver disease. In addition, the investigators will also look at whether the program improves weight loss, fatty liver disease, physical activity, diet, and family support among patients.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, if you are on SGLT2 inhibitors or GLP-1 agonists, you must be on a stable dose for at least 6 months before joining the study. Pioglitazone is allowed if you have been on a stable dose for 3 months prior to the study.
What data supports the effectiveness of the Paso Program treatment for fatty liver disease?
A structured and focused multidisciplinary clinical program, similar to the Paso Program, has been shown to stabilize body mass index (BMI) and reduce liver enzyme levels in children with fatty liver disease, suggesting potential benefits for managing the condition.
12345Is the Paso Program for Fatty Liver Disease safe for humans?
There is no specific safety data available for the Paso Program itself, but some treatments for fatty liver disease have known side effects. For example, pioglitazone can cause bone thinning and weight gain, while obeticholic acid may cause itching. More research is needed to fully understand the safety of these treatments.
678910How is the Paso Program treatment for fatty liver disease different from other treatments?
The Paso Program for fatty liver disease is unique because it likely involves a structured, multidisciplinary approach that focuses on weight management, which is crucial for improving fatty liver disease. Unlike standard drug treatments, this program may emphasize lifestyle changes and support, making it more comprehensive and potentially more effective for long-term management.
34111213Eligibility Criteria
This trial is for Mexican & Central American individuals with fatty liver disease linked to metabolic dysfunction, such as being overweight or having diabetes. It aims to see if the Paso weight loss program can help them.Inclusion Criteria
Self-reported Mexican or Central American ethnicity
BMI≥25kg/m2
I am between 18 and 70 years old.
+2 more
Exclusion Criteria
History of noncompliance (>3 primary care, endocrine, and/or hepatology clinic no-shows in the past year)
I have an active hepatitis infection or another chronic liver disease.
My HbA1c level is 9.0% or higher.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage in the Paso weight loss program, consisting of 16 1-hour group counseling classes over 6 months, focusing on healthy eating, physical activity, and behavioral strategies.
6 months
4 in-person classes, remaining classes can be attended in-person or virtually
Follow-up
Participants are monitored for changes in weight, liver health, and other health metrics at 4 time points over 1 year, including 6 months after the program ends.
6 months
Regular clinic visits, program sessions, or phone assessments
Participant Groups
The study tests the feasibility of the Paso Program—a weight loss initiative—on improving health outcomes like fatty liver disease, physical activity levels, diet quality, and family support in participants.
1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
All participants will receive the intervention, which is a behavioral weight loss program called "Paso a Paso: Rumbo a Un Higado Sano" ("Paso Program").
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Harris Health - SmithHouston, TX
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Who Is Running the Clinical Trial?
Baylor College of MedicineLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Evaluation of emerging NASH therapies: the impact of treatment efficacy profiles on long-term health outcomes. [2023]Aim: Evaluations of nonalcoholic steatohepatitis (NASH) treatments require predicting lifetime outcomes from short-term clinical trials. Materials & methods: A Markov model with NASH fibrosis stages F0-F3, NASH resolution, compensated cirrhosis (F4/CC), and liver-related complication (LRC) states was developed using literature-based standard of care (SoC) data. Hypothetical efficacy profiles were defined affecting resolution (100%-increase), fibrosis improvement (100% increase), or fibrosis worsening (50% decrease). Results: For the SoC, 10-year LRC rates increased with baseline fibrosis stage (F1: 3.0%; F2: 9.8%; F3: 27.2%; F4/CC: 64.9%). The fibrosis worsening profile reduced predicted 10-year LRC rates (F1: 1.9%; F2: 6.5%; F3: 19.1%; F4/CC: 55.0%) more than the resolution and fibrosis improvement profiles (F1: 2.6%/2.6%; F2: 8.5%/8.3%; F3: 23.3%/23.0%; F4/CC: NA/59.0%). Scenario analyses considered alternative SoC progression, treatment efficacy and treatment-stopping rules. Conclusion: Potential NASH efficacy profiles have differing impacts on predicted long-term outcomes, providing insights for future stakeholders.
Recommendations for the detection, diagnosis and follow-up of patients with non-alcoholic fatty liver disease in primary and hospital care. [2020]Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases, with a prevalence of 20-30% in the general population and 60-80% in at-risk populations. In a not negligible percentage of patients, NAFLD progresses from steatosis to different stages of fibrosis and cirrhosis. Due to its high prevalence, NAFLD has become a significant health problem that requires specific action in detection, diagnosis, follow-up and treatment. Furthermore, given that NAFLD presents an increased risk of cardiovascular morbidity and mortality, a multidisciplinary approach is required for its treatment and follow-up. Patients with early stages of the disease, without fibrosis, can be diagnosed and receive treatment in the Primary Care setting, while those with more advanced liver disease benefit from specialised follow-up in the hospital setting to prevent and treat liver complications. This consensus document, prepared by the Catalan Societies of Digestology, Primary Care, Endocrinology, Diabetes and Internal Medicine, arises from the need to design strategies to guide patient flows between Primary and Hospital Care in order to offer patients with NAFLD the best care according to the stage of their disease. The consensus document describes the most commonly used non-invasive diagnostic methods for patient diagnosis and two algorithms have been designed for patient management in both Primary Care and Hospital Care.
Weight Reduction and Pioglitazone are Cost-Effective for the Treatment of Non-Alcoholic Fatty Liver Disease in Thailand. [2020]This study evaluated lifetime liver-related clinical outcomes, costs of treatment, and the cost-effectiveness of treatment options for non-alcoholic fatty liver disease (NAFLD) in Thailand.
A multidisciplinary clinical program is effective in stabilizing BMI and reducing transaminase levels in pediatric patients with NAFLD. [2021]Weight loss is an effective treatment for children with nonalcoholic fatty liver disease (NAFLD), but it is extremely difficult to achieve outside of an intensive weight management program. We hypothesized that one can achieve success in improving NAFLD and weight-related outcomes in a structured and focused multidisciplinary clinical program feasible to implement in a gastroenterology clinic.
Modelling the cost effectiveness of non-alcoholic fatty liver disease risk stratification strategies in the community setting. [2021]Non-alcoholic fatty liver disease (NAFLD) is highly prevalent worldwide. Identifying high-risk patients is critical to best utilize limited health care resources. We established a community-based care pathway using 2D ultrasound shear wave elastography (SWE) to identify high risk patients with NAFLD. Our objective was to assess the cost-effectiveness of various non-invasive strategies to correctly identify high-risk patients.
Treatment options for nonalcoholic steatohepatitis - a safety evaluation. [2017]There is an urgent as yet unmet need to develop highly effective and safe therapeutics for nonalcoholic fatty liver disease (NAFLD). The remarkable progress in understanding NAFLD pathogenesis allowed the identification of injury pathways which may be recruited as therapy targets. Areas covered: This article reviews the safety and tolerability data of the NAFLD therapies and explains the mechanistic basis for each of the established and investigational drugs. Treatment targets include: weight loss, anti-metabolic agents such as lipid lowering and anti-diabetic drugs, inflammation, fibrosis and others such as targeting gut microbiota, immune modulation and apoptosis. Expert opinion: Current therapies continue to remain suboptimal. Weight loss is effective but hard to achieve. Traditional and endoscopic bariatric procedures are promising although more randomized trials are needed and the long-term safety remains to be established. Clinical trials have demonstrated the efficacy of several drugs for the treatment of NASH. Of these, there remains some uncertainty about the long-term safety of vitamin E. Pioglitazone is associated with osteopenia, fluid retention and weight gain. Obeticholic acid causes pruritus in a substantial proportion of subjects and elafibranor has been associated with transient rises in creatinine. Several exciting therapies are under development and results of clinical and post-marketing trials will help elucidate their safety.
Cilofexor, a Nonsteroidal FXR Agonist, in Patients With Noncirrhotic NASH: A Phase 2 Randomized Controlled Trial. [2021]We evaluated the safety and efficacy of cilofexor (formerly GS-9674), a small-molecule nonsteroidal agonist of farnesoid X receptor, in patients with nonalcoholic steatohepatitis (NASH).
Placebo Adverse Events in Non-alcoholic Steatohepatitis Clinical Trials: A Pooled Analysis of 2,944 Participants. [2023]In the absence of an effective treatment for non-alcoholic steatohepatitis (NASH), a randomized, placebo-controlled trial (RCT) remains the current gold standard study design in NASH. As NASH is a largely asymptomatic disease, the side effects of potential therapies require careful evaluation, therefore a pooled rate of the adverse events (AEs) in placebo-treated patients serves as a useful comparator for safety. Therefore, we performed a systematic review and meta-analysis to estimate the rate of AEs among participants in the placebo arm of NASH RCTs.
[Treating non-alcoholic fatty liver disease patients of Gan stagnation Pi deficiency syndrome by tiaogan lidi recipe: a randomized controlled clinical trial]. [2018]To evaluate the efficacy and safety of tiaogan Lipi Recipe (TLR) in treating non-alcoholic fatty liver disease (NAFLD) patients of Gan stagnation Pi deficiency syndrome (GSP-DS).
Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. [2023]This systematic review and meta-analysis was conducted to evaluate the efficacy and safety of 4 mg saroglitazar treatment in patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH).
Surgically-induced weight loss significantly improves nonalcoholic fatty liver disease and the metabolic syndrome. [2022]To evaluate the effects of surgical weight loss on fatty liver disease in severely obese patients.
Screening for nonalcoholic fatty liver disease-when, who and how? [2021]Nonalcoholic fatty liver disease (NAFLD) is becoming a frequent liver disease, especially in patients with metabolic syndrome and especially in Western countries. Complications of NAFLD comprise progressive fibrosis, cirrhosis and hepatocellular carcinoma. NAFLD also represents an independent risk factor for cardiovascular disease, extrahepatic neoplasia and other organ damage, such as renal insufficiency. Given the epidemiological importance of the disease, new developments in specific treatment of the disease and the wide availability of noninvasive techniques in estimating steatosis and fibrosis, NAFLD should be subject to screening programs, at least in countries with a high prevalence of the disease. The review discusses prerequisites for screening, cost-effectiveness, current guideline recommendations, suitability of techniques for screening and propositions for the following questions: Who should be screened? Who should perform screening? How should screening be performed? It is time for a screening program in patients at risk for NAFLD.
Complications, morbidity and mortality of nonalcoholic fatty liver disease. [2020]Nonalcoholic fatty liver disease (NAFLD) is an increasingly recognized public health problem, affecting up to a quarter of the world's adult population. The burden of NAFLD is influenced by the epidemics of obesity and type 2 diabetes mellitus (T2DM) and the prevalence of these conditions is not expected to decrease in the forthcoming decades. Consequently, the burden of NAFLD-related liver complications (non-alcoholic steatohepatitis [NASH], cirrhosis and hepatocellular carcinoma) and the need for life-saving liver transplantation are also expected to increase further in the near future. A large body of clinical evidence indicates that NAFLD is associated not only with increased liver-related morbidity and mortality, but also with an increased risk of developing other important extra-hepatic diseases, such as cardiovascular disease (that is the predominant cause of death in patients with NAFLD), extra-hepatic cancers (mainly colorectal cancers), T2DM and chronic kidney disease. Thus, NAFLD creates a considerable health and economic burden worldwide and often results in poor quality of life. This narrative review provides an overview of the current literature on main complications, morbidity and mortality of this common and burdensome liver disease.