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

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04186260
• Other study ID #: 1911187047
• Secondary ID: KMD014761A
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: December 29, 2025

Study information

• Verified date: May 2024
• Source: University of Arizona
• Contact: Paul Sandoval
• Phone: 520-626-6000
• Email: sponsor[@]email.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The Mexican-American population accounts for 64.3% of the U.S. Hispanic population and is the fastest growing Hispanic subgroup. Non-alcoholic fatty liver disease (NAFLD) is a chronic disease associated with obesity that is highest in the nation for Mexican-American men. NAFLD consists of a spectrum of conditions, ranging from fatty liver to cirrhosis and liver cancer. Lack of physical activity and sugar-sweetened beverage consumption are risk factors for NAFLD and are highly evident in the Mexican-American male population. Additionally, Mexican-American men are at increased risk of NAFLD and liver cancer if they are carriers of a version of a gene (PNPLA3) found to increase risk and severity of NAFLD. In the absence of prescription medications, weight loss due to changes in diet and physical activity is recommended for the prevention and treatment of NAFLD. Changes in lifestyle that result in >5% body weight loss have been shown to improve levels of liver fat and even reverse the condition. Despite the clear need to develop effective intervention strategies for Mexican-American men, no studies to date have explored the use of health risk assessment strategies, including genetic risk, to motivate behavior change to reduce the risk of NAFLD in Mexican-American men. Consequently, this will be the first weight loss intervention for Mexican-American men to incorporate genetic predisposition and lifestyle risk factors of NAFLD (e.g., dietary sugar consumption), as a strategy to improve engagement in weight loss and weight maintenance behaviors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: December 29, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Behavioral:
• NAFLD-specific weight loss intervention
This is a 12-month NAFLD-specific weight loss intervention that is explicitly tailored for Mexican-American men. It will include recommendations for diet, physical activity, and will utilize risk for NAFLD as a mechanism to engage men in lifestyle modification.

Other:
• Wait-list control
Participants in this condition will not receive treatment for 12-months until study comparisons have been made. After 12-months, participants will receive the 12-month NAFLD-specific weight loss intervention.

Locations

Country	Name	City	State
United States	University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available. — View Citation

Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available. Erratum In: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):3029-3030. — View Citation

Kallwitz ER, Daviglus ML, Allison MA, Emory KT, Zhao L, Kuniholm MH, Chen J, Gouskova N, Pirzada A, Talavera GA, Youngblood ME, Cotler SJ. Prevalence of suspected nonalcoholic fatty liver disease in Hispanic/Latino individuals differs by heritage. Clin Gastroenterol Hepatol. 2015 Mar;13(3):569-76. doi: 10.1016/j.cgh.2014.08.037. Epub 2014 Sep 15. — View Citation

Lazo M, Bilal U, Perez-Escamilla R. Epidemiology of NAFLD and Type 2 Diabetes: Health Disparities Among Persons of Hispanic Origin. Curr Diab Rep. 2015 Dec;15(12):116. doi: 10.1007/s11892-015-0674-6. — View Citation

Martinez LA, Larrieta E, Kershenobich D, Torre A. The Expression of PNPLA3 Polymorphism could be the Key for Severe Liver Disease in NAFLD in Hispanic Population. Ann Hepatol. 2017 November-December,;16(6):909-915. doi: 10.5604/01.3001.0010.5282. — View Citation

Musso G, Cassader M, Rosina F, Gambino R. 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. 2012 Apr;55(4):885-904. doi: 10.1007/s00125-011-2446-4. Epub 2012 Jan 27. — View Citation

Romeo S, Kozlitina J, Xing C, Pertsemlidis A, Cox D, Pennacchio LA, Boerwinkle E, Cohen JC, Hobbs HH. Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet. 2008 Dec;40(12):1461-5. doi: 10.1038/ng.257. Epub 2008 Sep 25. — View Citation

Saab S, Manne V, Nieto J, Schwimmer JB, Chalasani NP. Nonalcoholic Fatty Liver Disease in Latinos. Clin Gastroenterol Hepatol. 2016 Jan;14(1):5-12; quiz e9-10. doi: 10.1016/j.cgh.2015.05.001. Epub 2015 May 11. — View Citation

Severson TJ, Besur S, Bonkovsky HL. Genetic factors that affect nonalcoholic fatty liver disease: A systematic clinical review. World J Gastroenterol. 2016 Aug 7;22(29):6742-56. doi: 10.3748/wjg.v22.i29.6742. — View Citation

Tilg H, Moschen A. Weight loss: cornerstone in the treatment of non-alcoholic fatty liver disease. Minerva Gastroenterol Dietol. 2010 Jun;56(2):159-67. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Recruitment: Interest in Participation at Baseline	The number of Mexican-American men who express interest in participation.	Baseline
Primary	Study Recruitment: Screened for Eligibility at Baseline	The number of Mexican-American men screened for eligibility.	Baseline
Primary	Study Recruitment: Eligibility at Baseline	The number of Mexican-American men eligible/ineligible for study inclusion and reason for ineligibility.	Baseline
Primary	Study Recruitment: Enrollment at Baseline	The number of Mexican-American men enrolled in the study.	Baseline
Primary	Retention at 6-months	Retention will be measured as the number of participants who remain in the study at 6-months, divided by the number enrolled.	6-months
Primary	Retention at 12-months	Retention will be measured as the number of participants who remain in the study at 12-months, divided by the number enrolled.	12-months
Primary	Attendance at weekly counseling sessions at 6-months	The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 6-months.	6-months
Primary	Attendance at weekly counseling sessions at 12-months	The investigators will use descriptive analyses to examine attendance at weekly counseling sessions (% sessions attended) at 12-months.	12-months
Primary	Self-monitoring of dietary intake at 6-months	The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 6-months.	6-months
Primary	Self-monitoring of dietary intake at 12-months	The investigators will use descriptive analyses to examine self-monitoring of dietary intake (% days completed) at 12-months.	12-months
Primary	Self-monitoring of physical activity at 6-months	The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 6-months.	6-months
Primary	Self-monitoring of physical activity at 12-months	The investigators will use descriptive analyses to examine self-monitoring of physical activity (% days completed) at 12-months.	12-months
Primary	Self-weighing behaviors at 6-months	The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 6-months.	6-months
Primary	Self-weighing behaviors at 12-months	The investigators will use descriptive analyses to examine self-weighing behaviors (average days/week) at 12-months.	12-months
Primary	Intervention delivery time at 6-months	The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 6-months.	6-months
Primary	Intervention delivery time at 12-months	The investigators will use descriptive analyses to examine intervention delivery time (average minutes/week) at 12-months.	12-months
Primary	Treatment Satisfaction at 6-months: rating	Participants will be asked to rate their overall satisfaction (Treatment Satisfaction Survey; Minimum Score: 1 = very dissatisfied and Maximum Score: 4 = very satisfied) with the tailored weight loss intervention at 6-months.	6-months
Primary	Treatment Satisfaction at 12-months: rating	Participants will be asked to rate their overall satisfaction (Treatment Satisfaction Survey; Minimum Score: 1 = very dissatisfied and Maximum Score: 4 = very satisfied) with the tailored weight loss intervention at 12-months.	12-months
Secondary	Change in body weight at 6-months	Body weight (kg) will be measured on a digital scale to assess change in body weight at 6-months over the intervention period.	6-months
Secondary	Change in body weight at 12-months	Body weight (kg) will be measured on a digital scale to assess change in body weight at 12-months over the intervention period.	12-months
Secondary	Change in waist circumference at 6-months	Waist circumference (cm) will be assessed using a standardized protocol at 6-months.	6-months
Secondary	Change in waist circumference at 12-months	Waist circumference (cm) will be assessed using a standardized protocol at 12-months.	12-months
Secondary	Change in liver steatosis at 6-months	A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of fat (steatosis) present in the liver at 6-months based on controlled attenuation parameters (CAP).	6-months
Secondary	Change in liver steatosis at 12-months	A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of fat (steatosis) present in the liver at 12-months based on controlled attenuation parameters (CAP).	12-months
Secondary	Change in liver fibrosis at 6-months	A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of liver fibrosis (scaring) present in the liver at 6-months based on kilopascals (kPa).	6-months
Secondary	Change in liver fibrosis at 12-months	A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of liver fibrosis (scaring) present in the liver at 12-months based on kilopascals (kPa).	12-months
Secondary	Change in alanine aminotransferase (ALT) at 6-months	Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT) in Units/Liter (U/L) at 6-months.	6-months
Secondary	Change in alanine aminotransferase (ALT) at 12-months	Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT) in Units/Liter (U/L) at 12-months.	12-months
Secondary	Change in aspartate aminotransferase (AST) at 6-months	Fasting blood samples will be collected to examine changes in aspartate aminotransferase (AST) in Units/Liter (U/L) at 6-months.	6-months
Secondary	Change in aspartate aminotransferase (AST) at 12-months	Fasting blood samples will be collected to examine changes in aspartate aminotransferase (AST) in Units/Liter (U/L) at 12-months.	12-months
Secondary	Change in physical activity at 6-months	An Actigraph will be used to objectively measure and quantify energy expenditure from physical activity at 6-months.	6-months
Secondary	Change in physical activity at 12-months	An Actigraph will be used to objectively measure and quantify energy expenditure from physical activity at 12-months.	12-months
Secondary	Change in dietary intake at 6-months	24-hr recalls will be used to assess self reported food intake (kcal/day) at 6-months. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.	6-months
Secondary	Change in dietary intake at 12-months	24-hr recalls will be used to assess self reported food intake (kcal/day) at 12-months. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.	12-months
Secondary	Change in weight loss self-efficacy at 6-months: questionnaire	Change in weight loss self-efficacy at 6-months will be measured using a reliable and validated self reported questionnaire (Weight Efficacy Lifestyle Questionnaire; 10-point Likert scale from 0 (not confident) to 9 (very confident)).	6-months
Secondary	Change in weight loss self-efficacy at 12-months: questionnaire	Change in weight loss self-efficacy at 12-months will be measured using a reliable and validated self reported questionnaire (Weight Efficacy Lifestyle Questionnaire; 10-point Likert scale from 0 (not confident) to 9 (very confident)).	12-months