Weight loss intervention for Mexican-American men with NAFLD
A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men
This study tests a weight loss program designed for Mexican-American men with non-alcoholic fatty liver disease to see if it helps them improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | Male |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT04186260 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on Mexican-American men who are carriers of the PNPLA3 risk allele and have non-alcoholic fatty liver disease (NAFLD). Participants will be randomly assigned to receive a tailored weight loss intervention specifically designed for NAFLD or placed on a wait-list control group. The intervention aims to address lifestyle factors such as diet and physical activity, which are critical for managing NAFLD. This is the first study to incorporate genetic predisposition into a weight loss program targeting this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are Mexican or Mexican-American men aged 18-64 with a BMI between 30 to 50 kg/m² and identified as PNPLA3 risk allele carriers.
Not a fit: Patients with active gastrointestinal disorders, previous liver disease, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the prevalence and severity of NAFLD among Mexican-American men.
How similar studies have performed: While this specific approach is novel, previous studies have shown that lifestyle interventions can effectively improve NAFLD outcomes in similar populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tucson, Arizona
- University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment — Tucson, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: David O Garcia, PhD — University of Arizona, Mel & Enid Zuckerman College of Public Health
- Study coordinator: Paul Sandoval
- Email: sponsor@email.arizona.edu
- Phone: 520-626-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.