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临床试验/NCT02526732
NCT02526732已完成不适用

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

Priv.-Doz. Dr. J. Schattenberg2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Change in physical performance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • histologically proven NASH or fatty liver disease

排除标准

  • 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

研究组 & 干预措施

individual training program

Experimental

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.

干预措施: individual training program (Other)

结局指标

主要结局

Change in physical performance

时间窗: 0-8 weeks

Change of Vo2max from week 0 to week 8

次要结局

  • Change in liver inflammation(8 weeks)

研究者

发起方
Priv.-Doz. Dr. J. Schattenberg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Priv.-Doz. Dr. J. Schattenberg

Prov.-Doz. Dr. med.

Johannes Gutenberg University Mainz

研究点 (2)

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