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

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Moderate intensity aerobic exercise
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring fatty liver, NASH, NAFLD

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Moderate intensity aerobic exercise

    Arm Description

    All subjects will undergo DXA and CRF measurement (relative VO2max) under the supervision of an American College of Sports Medicine (ACSM)-certified fitness professional and study physician at the Penn State PM&R Research Laboratories. Subjects selected for the interventional pilot trial will receive a FitBit Charge2 HR and be instructed on how to use a FitBit Hear Rate monitor, Fitbit application, Fitbit website, and Fitabase (secure data management platform utilized by >400 clinical trials). Participants will record their daily food and beverage intake through the Fitbit app. Individualized feedback will be provided by a registered dietician (RD). 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.

    Outcomes

    Primary Outcome Measures

    hepatic fibrosis stage using METAVIR score
    The primary endpoint of this study is change in hepatic fibrosis stage.

    Secondary Outcome Measures

    fibrosis change and gains in cardiorespiratory fitness
    correlation between fibrosis change and gains in CRF
    flow mediated dilation
    correlation between fibrosis change and improvements in FMD
    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.
    intra-hepatic fat content
    changes in intra-hepatic fat content
    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.
    Body composition
    body composition change

    Full Information

    First Posted
    March 4, 2019
    Last Updated
    November 26, 2019
    Sponsor
    Milton S. Hershey Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03864835
    Brief Title
    NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal
    Acronym
    NASH-FITTER
    Official Title
    NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of funding
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Milton S. Hershey Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis
    Keywords
    fatty liver, NASH, NAFLD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Moderate intensity aerobic exercise
    Arm Type
    Experimental
    Arm Description
    All subjects will undergo DXA and CRF measurement (relative VO2max) under the supervision of an American College of Sports Medicine (ACSM)-certified fitness professional and study physician at the Penn State PM&R Research Laboratories. Subjects selected for the interventional pilot trial will receive a FitBit Charge2 HR and be instructed on how to use a FitBit Hear Rate monitor, Fitbit application, Fitbit website, and Fitabase (secure data management platform utilized by >400 clinical trials). Participants will record their daily food and beverage intake through the Fitbit app. Individualized feedback will be provided by a registered dietician (RD). 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Moderate intensity aerobic exercise
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    hepatic fibrosis stage using METAVIR score
    Description
    The primary endpoint of this study is change in hepatic fibrosis stage.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    fibrosis change and gains in cardiorespiratory fitness
    Description
    correlation between fibrosis change and gains in CRF
    Time Frame
    12 months
    Title
    flow mediated dilation
    Description
    correlation between fibrosis change and improvements in FMD
    Time Frame
    12 months
    Title
    NAFLD Activity Score (NAS)
    Description
    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.
    Time Frame
    12 months
    Title
    intra-hepatic fat content
    Description
    changes in intra-hepatic fat content
    Time Frame
    12 months
    Title
    health related quality of life (HRQOL)
    Description
    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.
    Time Frame
    12 months
    Title
    Body composition
    Description
    body composition change
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan G Stine, MD
    Organizational Affiliation
    Milton S. Hershey Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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