50 Participants Needed

Paso Program for Fatty Liver Disease

MB
Overseen ByMaya Balakrishnan, MD MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

Is 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.678910

How 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.34111213

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.

Research Team

MB

Maya Balakrishnan

Principal Investigator

Baylor College of Medicine

Eligibility 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 have been diagnosed with MASLD, showing liver fat and a metabolic condition.
See 1 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.
See 15 more

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

Treatment Details

Interventions

  • Paso Program
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Findings from Research

A Markov model was developed to predict long-term outcomes for nonalcoholic steatohepatitis (NASH) treatments, showing that higher baseline fibrosis stages significantly increase the risk of liver-related complications over 10 years.
The model indicated that a treatment profile focused on reducing fibrosis worsening had the most substantial impact on lowering long-term complication rates, suggesting that managing fibrosis progression is crucial in NASH treatment strategies.
Evaluation of emerging NASH therapies: the impact of treatment efficacy profiles on long-term health outcomes.Herring, WL., Gould, IG., Wittrup-Jensen, V., et al.[2023]
Non-alcoholic fatty liver disease (NAFLD) affects 20-30% of the general population and can progress to serious liver conditions, highlighting the need for effective detection and treatment strategies.
A multidisciplinary approach is essential for managing NAFLD, with early-stage patients being treated in Primary Care and those with advanced disease requiring specialized hospital care, supported by non-invasive diagnostic methods and management algorithms.
Recommendations for the detection, diagnosis and follow-up of patients with non-alcoholic fatty liver disease in primary and hospital care.Caballeria, L., Augustin, S., Broquetas, T., et al.[2020]
A weight reduction program is the most effective treatment for non-alcoholic fatty liver disease (NAFLD), preventing cirrhosis and hepatocellular carcinoma (HCC) cases by 13.91% and 2.12%, respectively, while also being the most cost-effective option in Thailand.
Pioglitazone and vitamin E showed some potential in reducing cirrhosis and HCC cases, but their effectiveness and cost-effectiveness were significantly lower compared to the weight reduction program, which had a 76% probability of being cost-effective.
Weight Reduction and Pioglitazone are Cost-Effective for the Treatment of Non-Alcoholic Fatty Liver Disease in Thailand.Chongmelaxme, B., Phisalprapa, P., Sawangjit, R., et al.[2020]

References

Evaluation of emerging NASH therapies: the impact of treatment efficacy profiles on long-term health outcomes. [2023]
Recommendations for the detection, diagnosis and follow-up of patients with non-alcoholic fatty liver disease in primary and hospital care. [2020]
Weight Reduction and Pioglitazone are Cost-Effective for the Treatment of Non-Alcoholic Fatty Liver Disease in Thailand. [2020]
A multidisciplinary clinical program is effective in stabilizing BMI and reducing transaminase levels in pediatric patients with NAFLD. [2021]
Modelling the cost effectiveness of non-alcoholic fatty liver disease risk stratification strategies in the community setting. [2021]
Treatment options for nonalcoholic steatohepatitis - a safety evaluation. [2017]
Cilofexor, a Nonsteroidal FXR Agonist, in Patients With Noncirrhotic NASH: A Phase 2 Randomized Controlled Trial. [2021]
Placebo Adverse Events in Non-alcoholic Steatohepatitis Clinical Trials: A Pooled Analysis of 2,944 Participants. [2023]
[Treating non-alcoholic fatty liver disease patients of Gan stagnation Pi deficiency syndrome by tiaogan lidi recipe: a randomized controlled clinical trial]. [2018]
Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Surgically-induced weight loss significantly improves nonalcoholic fatty liver disease and the metabolic syndrome. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Screening for nonalcoholic fatty liver disease-when, who and how? [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Complications, morbidity and mortality of nonalcoholic fatty liver disease. [2020]
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