NCT04186260Completed
A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men
Source: ClinicalTrials.gov · Last updated 24 Aug 2025
Brief summary (registry, in English)
Using a small Randomized Controlled Trial (RCT) study design, PNPLA3 risk allele carriers (CG/GG genotype) with NAFLD, will be assigned 2:1 to a tailored NAFLD-specific weight loss intervention compared to a wait-list control group.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 27 Nov 2019
- Start date
- 5 Feb 2024
- Primary completion date
- 30 May 2025
- Lead sponsor
- University of Arizona
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04186260
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 5 Feb 2024 to the primary completion date, 30 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Been previously diagnosed with viral hepatitis, liver disease or liver cancer
- 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
Other illness
- Have active, chronic gastrointestinal disorder (e.g. inflammatory bowel disease, ulcerative colitis, Chron's disease, celiac disease)
- 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 an eating disorders that would contraindicate weight loss or physical activity
- Taking any medication or supplement known to affect body composition or history of exposure to hepatotoxic drugs
Other
- Have a resting systolic blood pressure of ≥150 mmHg or resting diastolic blood pressure of ≥100 mmHg
- 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
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.