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

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ClinicalTrials.gov Identifier: NCT03864835
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Stine, Milton S. Hershey Medical Center

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 48 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). From this larger group of 48 people, 12 with the most severe scarring will be selected for the exercise intervention.


Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis NASH - Nonalcoholic Steatohepatitis Behavioral: Moderate intensity aerobic exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: Moderate intensity aerobic exercise
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.
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.




Primary Outcome Measures :
  1. hepatic fibrosis stage using METAVIR score [ Time Frame: 12 months ]
    The primary endpoint of this study is change in hepatic fibrosis stage.


Secondary Outcome Measures :
  1. fibrosis change and gains in cardiorespiratory fitness [ Time Frame: 12 months ]
    correlation between fibrosis change and gains in CRF

  2. flow mediated dilation [ Time Frame: 12 months ]
    correlation between fibrosis change and improvements in FMD

  3. NAFLD Activity Score (NAS) [ Time Frame: 12 months ]
    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.

  4. intra-hepatic fat content [ Time Frame: 12 months ]
    changes in intra-hepatic fat content

  5. health related quality of life (HRQOL) [ Time Frame: 12 months ]
    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.

  6. Body composition [ Time Frame: 12 months ]
    body composition change



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Adults age >=18 or <70 years
  • Liver biopsy <= 6months prior to enrollment
  • Biopsy proven NASH with NASH >5 (78)
  • Lack of secondary causes of hepatic fat accumulation

Exclusion Criteria

  • >90 minutes/week of at least moderate intensity exercise over the previous three months as assessed by the Get Active Questionnaire (GAQ).
  • Pregnancy
  • BMI <18 or >45 kg/m2(45)
  • Uncontrolled diabetes (changes in medication dosing over the previous three months or hemoglobin A1c >9%)(8)
  • Active cardiac symptoms
  • Severe medical comorbidities/psychiatric illness
  • Decompensated cirrhosis (history of esophageal varices, ascites or hepatic encephalopathy)
  • Abdominal hernia
  • Cancer with life expectancy <6 months
  • Other liver disease (e.g., positive hepatitis B surface antigen)
  • Active weight-loss program participation or weight-loss supplement use
  • Active substance abuse/smoking
  • Inability to provide informed consent
  • Institutionalized/prisoner
  • Inability to walk > 2 blocks or ¼ mile
  • Non-English-speaking patients due to unavailability of translators for all visits/sessions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864835


Contacts
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Contact: Gloriany Rivas, BA (717) 531-0003 ext 320223 grivas@pennstatehealth.psu.edu
Contact: Jonathan G Stine, MD (717) 531-1017 jstine@pennstatehealth.psu.edu

Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Jonathan G Stine, MD Milton S. Hershey Medical Center

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Responsible Party: Jonathan Stine, Center Assistant Professor of Medicine and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03864835     History of Changes
Other Study ID Numbers: STUDY00011797
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Jonathan Stine, Milton S. Hershey Medical Center:
fatty liver
NASH
NAFLD

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases