NAFLD-specific weight loss intervention for Nonalcoholic Steatohepatitis
Phase-Based Progress Estimates
Effectiveness
Safety
Nonalcoholic Steatohepatitis+1 More
NAFLD-specific weight loss intervention - BehavioralEligibility
18 - 65
Male
What conditions do you have?
Select
Eligibility
18 - 65
Male
What conditions do you have?
Select
Study Summary
This trial will study whether a weight loss intervention specifically for people with NAFLD and the PNPLA3 risk allele will be more effective than no intervention.
Eligible Conditions
- Nonalcoholic Steatohepatitis
- (NAFLD)
Treatment Effectiveness
Study Objectives
18 Primary · 18 Secondary · Reporting Duration: 12-months
12-months
Attendance at weekly counseling sessions at 12-months
Change in alanine aminotransferase (ALT) at 12-months
Change in aspartate aminotransferase (AST) at 12-months
Change in body weight at 12-months
Change in dietary intake at 12-months
Change in liver fibrosis at 12-months
Change in liver steatosis at 12-months
Change in physical activity at 12-months
Change in waist circumference at 12-months
Change in weight loss self-efficacy at 12-months: questionnaire
Intervention delivery time at 12-months
Retention at 12-months
Self-monitoring of dietary intake at 12-months
Self-monitoring of physical activity at 12-months
Self-weighing behaviors at 12-months
Treatment Satisfaction at 12-months: rating
6-months
Attendance at weekly counseling sessions at 6-months
Change in alanine aminotransferase (ALT) at 6-months
Change in aspartate aminotransferase (AST) at 6-months
Change in body weight at 6-months
Change in dietary intake at 6-months
Change in liver fibrosis at 6-months
Change in liver steatosis at 6-months
Change in physical activity at 6-months
Change in waist circumference at 6-months
Change in weight loss self-efficacy at 6-months: questionnaire
Intervention delivery time at 6-months
Retention at 6-months
Self-monitoring of dietary intake at 6-months
Self-monitoring of physical activity at 6-months
Self-weighing behaviors at 6-months
Treatment Satisfaction at 6-months: rating
Baseline
Study Recruitment: Eligibility at Baseline
Study Recruitment: Enrollment at Baseline
Study Recruitment: Interest in Participation at Baseline
Study Recruitment: Screened for Eligibility at Baseline
Trial Safety
Trial Design
1 Treatment Group
NAFLD-specific weight loss intervention
1 of 1
Experimental Treatment
39 Total Participants · 1 Treatment Group
Primary Treatment: NAFLD-specific weight loss intervention · No Placebo Group · N/A
NAFLD-specific weight loss intervention
Behavioral
Experimental Group · 1 Intervention: NAFLD-specific weight loss intervention · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12-months
Who is running the clinical trial?
University of ArizonaLead Sponsor
456 Previous Clinical Trials
156,115 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
280 Previous Clinical Trials
702,245 Total Patients Enrolled
David O Garcia, PhDPrincipal InvestigatorUniversity of Arizona, Mel & Enid Zuckerman College of Public Health
1 Previous Clinical Trials
50 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · Male Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You self-identify as a Mexican or Mexican-American man.
You are a carrier of the PNPLA3 risk allele.
About The Reviewer
Michael Gill - B. Sc.
First Published: October 28th, 2021
Last Reviewed: November 29th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Jensen, Michael D., Donna H. Ryan, Caroline M. Apovian, Jamy D. Ard, Anthony G. Comuzzie, Karen A. Donato, Frank B. Hu, et al.. 2014. “2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2013.11.004.
- Martínez, Leonardo A., Elena Larrieta, Juan J. Calva, David Kershenobich, and Aldo Torre. 2017. “The Expression of PNPLA3 Polymorphism Could Be the Key for Severe Liver Disease in NAFLD in Hispanic Population”. Annals of Hepatology. Elsevier BV. doi:10.5604/01.3001.0010.5282.
- Kallwitz, Eric R., Martha L. Daviglus, Matthew A. Allison, Kristen T. Emory, Lihui Zhao, Mark H. Kuniholm, Jinsong Chen, et al.. 2015. “Prevalence of Suspected Nonalcoholic Fatty Liver Disease in Hispanic/latino Individuals Differs by Heritage”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2014.08.037.
- Saab, Sammy, Vignan Manne, Jose Nieto, Jeffrey B. Schwimmer, and Naga P. Chalasani. 2016. “Nonalcoholic Fatty Liver Disease in Latinos”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2015.05.001.
- Lazo, Mariana, Usama Bilal, and Rafael Perez-Escamilla. 2015. “Epidemiology of NAFLD and Type 2 Diabetes: Health Disparities Among Persons of Hispanic Origin”. Current Diabetes Reports. Springer Science and Business Media LLC. doi:10.1007/s11892-015-0674-6.
- Severson, Tyler J, Siddesh Besur, and Herbert L Bonkovsky. 2016. “Genetic Factors That Affect Nonalcoholic Fatty Liver Disease: A Systematic Clinical Review”. World Journal of Gastroenterology. Baishideng Publishing Group Inc.. doi:10.3748/wjg.v22.i29.6742.
- Romeo, Stefano, Julia Kozlitina, Chao Xing, Alexander Pertsemlidis, David Cox, Len A Pennacchio, Eric Boerwinkle, Jonathan C Cohen, and Helen H Hobbs. 2008. “Genetic Variation in PNPLA3 Confers Susceptibility to Nonalcoholic Fatty Liver Disease”. Nature Genetics. Springer Science and Business Media LLC. doi:10.1038/ng.257.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Chalasani, Naga, Zobair Younossi, Joel E. Lavine, Michael Charlton, Kenneth Cusi, Mary Rinella, Stephen A. Harrison, Elizabeth M. Brunt, and Arun J. Sanyal. 2017. “The Diagnosis and Management of Nonalcoholic Fatty Liver Disease: Practice Guidance from the American Association for the Study of Liver Diseases”. Hepatology. Wiley. doi:10.1002/hep.29367.
- Musso, G., M. Cassader, F. Rosina, and R. Gambino. 2012. “Impact of Current Treatments on Liver Disease, Glucose Metabolism and Cardiovascular Risk in Non-alcoholic Fatty Liver Disease (NAFLD): A Systematic Review and Meta-analysis of Randomised Trials”. Diabetologia. Springer Science and Business Media LLC. doi:10.1007/s00125-011-2446-4.
- 2023. "A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04186260.
Popular Clinical Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments