Hepatic Inflammation and Physical Performance in Patients With NASH — HELP  

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title: Influence of Hepatic Inflammation and Hepatocellular Apoptosis on Physical Performance and Training Effect in Patients With Non - Alcoholic Steatohepatitis

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fatty Liver
• Inflammation
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

• NCT number: NCT02526732
• Study type: Interventional
• Source: Johannes Gutenberg University Mainz
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Completion date: December 20, 2017