Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.
Outpatients with NASH will be included into this lifestyle intervention study. Patients will get nutritional advices and a formula diet for 12 weeks. Clinical visits will take place at baseline, after 4, 12 and after 52 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Formula diet for 12 weeks
Düsseldorf Catholic Hospital Group
Düsseldorf, Germany
Praxis Prof. Erhardt
Wuppertal, Germany
degree of steatosis
degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
Time frame: 12 weeks
degree of steatosis
degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
Time frame: 52 weeks
degree of fibrosis
degree of fibrosis in meter per second (m/s) measured by Acoustic Radiation Force Impulse (ARFI) elastography
Time frame: 12 weeks and 52 weeks
fat mass
fatt mass in kilogram (kg) measured by Bioelectrical Impedance Analysis (BIA)
Time frame: 12 weeks and 52 weeks
Glutamate Pyruvate Transaminase (GPT)
Glutamate Pyruvate Transaminase in units/litre (U/L)
Time frame: 12 weeks and 52 weeks
Gamma-glutamyltransferase (GGT)
Gamma-glutamyltransferase in units/litre (U/L)
Time frame: 12 weeks and 52 weeks
insulin
insulin in micro units per millilitre (µU/ml)
Time frame: 12 weeks and 52 weeks
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