Active — Not RecruitingNot Applicable

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

United States50 participantsStarted 2025-02-05

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. ≥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:
✕. 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

What they're measuring

Feasbility

Timeframe: 6 months

Trial details

NCT IDNCT06854185

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-05

View on ClinicalTrials.gov More Metabolic Dysfunction Associated Steatotic Liver Disease trials