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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02526732 |
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Date of registration:
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17/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Hepatic Inflammation and Physical Performance in Patients With NASH
HELP |
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Scientific title:
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Influence of Hepatic Inflammation and Hepatocellular Apoptosis on Physical Performance and Training Effect in Patients With Non - Alcoholic Steatohepatitis |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02526732 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Peter R Galle, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz |
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Key inclusion & exclusion criteria
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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
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- 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-alcoholic Fatty Liver Disease
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Intervention(s)
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Other: individual training program
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Primary Outcome(s)
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Change in physical performance
[Time Frame: 0-8 weeks]
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Secondary Outcome(s)
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Change in liver inflammation
[Time Frame: 8 weeks]
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Secondary ID(s)
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2015_04_001_HELP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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