Clinical trial NCT03864835: NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal
Official title: NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Non Alcoholic Steatohepatitis
NASH - Nonalcoholic Steatohepatitis
Keywords: fatty liver
NASH
NAFLD
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: hepatic fibrosis stage using METAVIR score
timeFrame: 12 months
Secondary outcomes:
measure: fibrosis change and gains in cardiorespiratory fitness
timeFrame: 12 months
measure: flow mediated dilation
timeFrame: 12 months
measure: NAFLD Activity Score (NAS)
timeFrame: 12 months
measure: intra-hepatic fat content
timeFrame: 12 months
measure: health related quality of life (HRQOL)
timeFrame: 12 months
measure: Body composition
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Jonathan G Stine, MD
role: PRINCIPAL_INVESTIGATOR
References: