Hepatic Inflammation and Physical Performance in Patients With NASH
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Inflammation
Study type: Interventional

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.
    

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.
    

Intervention name(s): individual training program
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: NASH; fatty Liver; VO2 max; M30 antigen