Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-28 @ 12:47 AM
Study NCT ID:
NCT03864835
Status:
WITHDRAWN
Last Update Posted:
2019-11-29
First Post:
2019-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal
Sponsor:
Milton S. Hershey Medical Center
Organization:
Study Overview
Official Title:
NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal
Status:
WITHDRAWN
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NASH-FITTER
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).
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: