A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men

Launched by UNIVERSITY OF ARIZONA · Dec 2, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a specific way to help Mexican-American men who have a condition called non-alcoholic fatty liver disease (NAFLD). The study will focus on men who carry a certain genetic risk factor and are overweight. Participants will be divided into two groups: one group will receive a special weight loss program designed for NAFLD, while the other group will be placed on a waitlist and won't receive the program right away.

To be eligible for this study, participants need to be Mexican or Mexican-American men between the ages of 18 and 64, with a body mass index (BMI) between 30 and 50. They must also have a certain score related to liver fat and carry the specific genetic risk factor. Throughout the study, participants can expect to engage in activities aimed at weight loss and improving their liver health, while also receiving support tailored to their culture and needs. It’s important to note that some medical conditions or treatments may disqualify individuals from participating, so a thorough screening will be conducted.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Self-identify as a Mexican or Mexican-American man
• • 18-64 years of age
• • BMI between 30 to 50.0 kg/m²
• • Have a CAP score ≥248 at screening
• • Be identified as PNPLA3 risk allele carriers (CG/GG genotype) at screening
• • Be able to provide informed consent
• • Speak, read, and write either English and/or Spanish.
• Exclusion Criteria:
• • Have active, chronic gastrointestinal disorder (e.g. inflammatory bowel disease, ulcerative colitis, Chron's disease, celiac disease)
• • Been previously diagnosed with viral hepatitis, liver disease or liver cancer
• • Have a history of bariatric surgery
• • Report medical condition or treatment for a medical condition that could affect body weight or ability to engage in structured physical activity that is consistent with the intervention for this study
• • Have current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event
• • Have a resting systolic blood pressure of ≥150 mmHg or resting diastolic blood pressure of ≥100 mmHg
• • Have an eating disorders that would contraindicate weight loss or physical activity
• • Report significant alcohol consumption (e.g., drinking ≥ 21 standard drinks/week, binge drinkers, or those with previous heavy alcohol consumption) identified by the Alcohol Use Disorders Identification Test
• • Currently treated for psychological issues (e.g., depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years
• • Report exercise on ≥3 days per week for ≥ 20 minutes per day over the past 3 months
• • Report weight loss of ≥5% or participating in a weight reduction diet program in the past 3 months
• • Taking any medication or supplement known to affect body composition or history of exposure to hepatotoxic drugs
• • Report plans to relocate to a location that limits their access to the study site or having employment, personal, or travel commitments that prohibit attendance to all of the scheduled assessments.