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Hepatic Inflammation and Physical Performance in Patients With NASH (HELP)

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ClinicalTrials.gov Identifier: NCT02526732
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Priv.-Doz. Dr. J. Schattenberg, Johannes Gutenberg University Mainz

Brief Summary:
The aim of the study is to examine the influence of hepatic inflammation or damage on physical performance (maximal oxygen uptake, VO2max) depending on the histologic state of the liver. The study population are patients with fatty liver disease and non-alcoholic steatohepatitis (NASH). All study participants obtain an individual training plan with individual and group training sessions for a period of 8 weeks. At the beginning and end of the training phase a sport physiological examination is carried out. In the study group the effect of regular examinations is surveyed by surrogate parameters of liver inflammation.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Other: individual training program Not Applicable

Detailed Description:
The study is planned over a period of 24 months. Study participants should be twice examined sport physiologically in a period of 12 weeks. In the study group the influence of regular exercise on surrogate parameters of liver inflammation is investigated over a study period of 8 weeks. Before the exercise all study participants are subjected to a first physiological examination (about 3 hours). This includes a physical examination with detection of body weight, waist circumference and body fat analysis, venous blood, oral glucose tolerance test, ultrasonography of the liver and determination of endothelial function (flow-mediated vasodilatation, FMD) by Doppler analysis. Within 4 weeks after the first examination a sport physical examination is carried out at the Institute of Sports Science at the University of Mainz. This examination contains identification of physical fitness and individual lactate performance diagnostics. In addition, indirect calorimetry is carried out under exercise conditions using spiroergometry to determine the maximal oxygen uptake (VO2max) with special emphasis on the fat metabolism rate at low physical activity. Subsequently to the examination an 8-week training period based on individual training / performance plans is followed. The training plans include independently running exercises for 30-45 minutes two to three times a week. Every two weeks group training sessions are offered accompanied by a sports physician. Within the planed four groups training sessions blood samples will be taken to determinate free circulating DNA and assess lactate values under exercise conditions. After the training phase, a second sport physical examination including physical performance and a final physiological examination including surrogate parameters of liver inflammation are carried out. For statistical analysis, the physical performance of the study participants is examined. Hence patients with histologically proven NASH (NAS score) and confirmed inflammation (increased M30 antigen) are compared to age and gender matched patients with histologically proven fatty liver without inflammation reaction as well as to retrospective data of healthy subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Influence of Hepatic Inflammation and Hepatocellular Apoptosis on Physical Performance and Training Effect in Patients With Non - Alcoholic Steatohepatitis
Study Start Date : September 2015
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017


Arm Intervention/treatment
Experimental: individual training program
Patients will be offered an individual training program. Physical performance and surrogate parameters of liver inflammation will assessed in physical examinations before and after the training phase.
Other: individual training program
Training period of 8 weeks: Independently running exercises for 30-45 minutes two to three times a week. Every two weeks group training sessions are offered accompanied by a sports physician.




Primary Outcome Measures :
  1. Change in physical performance [ Time Frame: 0-8 weeks ]
    Change of Vo2max from week 0 to week 8


Secondary Outcome Measures :
  1. Change in liver inflammation [ Time Frame: 8 weeks ]
    Change of NAS score at week 0 and week 8



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically proven NASH or fatty liver disease

Exclusion Criteria:

  • bariatric surgery within the last 5 years
  • BMI< 18,5 kg/m2 or > 45 kg/m2
  • heart attack or stroke within the last 6 months
  • higher-grade coronary artery disease (CAD III-IV)
  • chronic obstructive pulmonary disease (asthma , COPD)
  • renal insufficiency
  • uncontrolled hypertension or metabolic abnormalities
  • alcohol consumption > 30 g / day (male) and > 20 g / day (female)
  • pregnancy
  • concomitant medication able to cause a secondary NASH (eg tamoxifen , corticosteroids )
  • concomitant medication able to affect inflammation (eg TNF antagonists)
  • concomitant anticoagulant medication (eg phenprocoumon, NOAC)
  • other immunological or inflammatory diseases (eg, systemic lupus erythematosus)
  • musculoskeletal disorders, preventing sport physiological investigations

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): NCT02526732


Locations
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Germany
University Medical Center of the Johannes Gutenber Univeristy
Mainz, Germany, 55131
Sponsors and Collaborators
Priv.-Doz. Dr. J. Schattenberg
Investigators
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Study Director: Peter R Galle, MD I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Priv.-Doz. Dr. J. Schattenberg, Prov.-Doz. Dr. med., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02526732     History of Changes
Other Study ID Numbers: 2015_04_001_HELP
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in scientific journals and conferences

Keywords provided by Priv.-Doz. Dr. J. Schattenberg, Johannes Gutenberg University Mainz:
NASH
fatty Liver
VO2 max
M30 antigen

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