NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal

Non-Alcoholic Fatty Liver Disease Clinical Trial

— NASH-FITTER  

Official title:

NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03864835
• Other study ID #: STUDY00012210
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research is being done to find out if aerobic exercise is beneficial in reversing scarring. Physical activity has been shown to increase fitness in healthy individuals as well as in those with NASH. This research will allow for better understanding the effects of physical activity on fitness and endothelial function in patients with NASH with the goal of reversing scarring.

Approximately 12 people will take part in this research study at Penn State (PSU) Milton S. Hershey Medical Center (HMC), Penn State Physical Medicine & Research (PM&R) Laboratories housed at the Hershey Center for Applied Research (HCAR) and the Penn State University Fitness Center (UFC).

Description:

Preliminary studies show universally low cardiorespiratory fitness (CRF) in Nonalcoholic steatohepatitis (NASH) patients was dependent on body composition. The proposed work is based on the hypothesis that gains in cardiorespiratory fitness and improved endothelial function achieved through exercise can arrest or reverse progression of hepatic fibrosis, lessen cardiovascular disease risk (CVD), and improve all-cause mortality in patients with NASH. The aims of this research proposal are designed to characterize and better understand the effects of physical activity (PA) on CRF and endothelial function in patients with NASH. The goal is to arrest progression of fibrosis and reduce CVD risk. This proposal includes a cross-sectional study and a small pilot clinical trial in a high-risk subgroup of NASH most likely to benefit from PA.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria

•Enrollment and completion of IRB study # 00011797

Exclusion Criteria

• Inability to provide informed consent

• Institutionalized/prisoner

• Non-English-speaking patients due to unavailability of translators for all visits/sessions

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NASH - Nonalcoholic Steatohepatitis
• Non Alcoholic Steatohepatitis
• Non-Alcoholic Fatty Liver Disease

Intervention

Behavioral:
• Moderate intensity aerobic exercise
Subjects that meet requirements for the exercise arm (12 total) will be required to exercise 30 minutes, five days per week at a moderate intensity (HR target corresponding to 45-55% of their relative VO2max). Each session will be supervised in-person at the Penn State University Fitness Center with an ACSM certified exercise physiologist. This is feasible as Zhang et al.(87) found 66 out of 70 subjects (95%) completed the twelve-month supervised in-person moderate-intensity exercise protocol five-days a week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatic fibrosis stage using METAVIR score	The primary endpoint of this study is change in hepatic fibrosis stage.	12 months
Secondary	fibrosis change and gains in cardiorespiratory fitness	correlation between fibrosis change and gains in CRF	12 months
Secondary	flow mediated dilation	correlation between fibrosis change and improvements in FMD	12 months
Secondary	NAFLD Activity Score (NAS)	The diagnosis of nonalcoholic steatohepatitis (NASH) is defined by the presence and pattern of specific histological abnormalities on liver biopsy. A separate system of scoring the features of nonalcoholic fatty liver disease (NA) called the NAFLD Activity Score (NAS) was developed as a tool to measure changes in NAFLD. The grading or NAFLD activity score (NAS) encompasses steatosis, lobular inflammation and ballooning.	12 months
Secondary	intra-hepatic fat content	changes in intra-hepatic fat content	12 months
Secondary	health related quality of life (HRQOL)	PROMIS is a computer adaptive test (CATs) used to assess health related quality of life. The survey contains profiles that measure multiple concepts through a fixed collection of short forms.	12 months
Secondary	Body composition	body composition change	12 months