Feasibility of the Paso Program for Patients With Metabolic Dysfunction Associated Steatotic Liver Disease

Running, not enrolling · Not applicable

Conditions studied: Metabolic Dysfunction Associated Steatotic Liver Disease, Overweight (BMI > 25), Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT06854185

Run by

Baylor College of Medicine

People needed

50

Starts

2025-02-05

Expected to finish

2026-12-31

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with MASLD (defined per guideline based diagnostic criteria: evidence of steatosis with at least 1 metabolic syndrome feature)
• Self-reported Mexican or Central American ethnicity
• Age between 18 and 70 years
• BMI≥25kg/m2
• Able to read and write English and/or Spanish

You may not qualify if…

• ≥5% weight loss over the prior 3 months
• HbA1c ≥9.0% within 30 days of weight loss program initiation*
• History of bariatric surgery
• Advanced liver disease, defined as:
• platelet count < 150,000, serum albumin <3.5 g/dL, except as explained by non-hepatic causes. INR >1.4 unless due to therapeutic anticoagulants or laboratory error. Total bilirubin ≥2 mg/dL (unless explained by Gilbert Syndrome). Presence of esophageal varices,
• Any history of liver disease decompensations** or hepatocellular carcinoma,
• History of any organ transplant (including liver transplant)
• Active HCV infection (defined as HCV Ab positive with detectable viral load)*, Hepatitis B infection (defined as positive HBsAg) and/or other etiologies of chronic liver disease (AIH, PBC, Wilson disease, PSC) or acute hepatic injury.
• Ongoing heavy alcohol use defined as 320-420grams/week
• SGLT2 inhibitor or Glucagon-like peptide 1 (GLP-1) agonist therapy for diabetes treatment (e.g., exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide, and albiglutide) or for weight loss (e.g., semaglutide at doses up to 2.4 mg subcutaneous weekly) must be at a stable dose for at least 6 months prior to study entry with stable weight (defined as <5% weight loss in the 12 weeks prior to study entry)*
• Pioglitazone is allowed if on a stable dose for 3 months prior to study entry
• current pregnancy/nursing or planned pregnancy
• conditions limiting dietary calorie reduction or physical activity
• Active cancer, except for example non-melanoma skin cancers or cancers that have clearly been cured, stable and being monitored by primary doctor or oncologist without active treatment, or carries an excellent prognosis (e.g., Stage 1 cervical cancer)
• unstable cardiac disease
• intestinal resection or malabsorption disorders
• life expectancy<2 years
• competing serious medical or psychiatric comorbidity
• HIV infection
• History of noncompliance (>3 primary care, endocrine, and/or hepatology clinic no-shows in the past year)

Where it is running

• Harris Health - Smith — Houston, Texas, United States

Full record on ClinicalTrials.gov

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