Phase
Condition
Obesity
Diabetes Prevention
Metabolic Syndrome
Treatment
Paso Program
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed with MASLD (defined per guideline based diagnostic criteria: evidence ofsteatosis 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
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: platelet count < 150,000, serum albumin <3.5 g/dL, except as explained bynon-hepatic causes. INR >1.4 unless due to therapeutic anticoagulants or laboratoryerror. Total bilirubin ≥2 mg/dL (unless explained by Gilbert Syndrome). Presence ofesophageal 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 chronicliver 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 diabetestreatment (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 tostudy entry with stable weight (defined as <5% weight loss in the 12 weeks prior tostudy 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 haveclearly been cured, stable and being monitored by primary doctor or oncologistwithout active treatment, or carries an excellent prognosis (e.g., Stage 1 cervicalcancer)
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 clinicno-shows in the past year)
Study Design
Study Description
Connect with a study center
Harris Health - Smith
Houston, Texas 77030
United StatesSite Not Available

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