Steatohepatitis, Nonalcoholic
Conditions
Keywords
overweight, fatty liver
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTFormula diet
Formula diet for 12 weeks
Sponsors
West German Center of Diabetes and Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Lifestyle intervention including formula diet
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* BMI\>25 kg/qm
Exclusion criteria
* history of drug or alcohol abuse * acute or chronic diseases (except type 2 diabetes) * pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| degree of steatosis | 12 weeks | degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| degree of steatosis | 52 weeks | degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation |
| degree of fibrosis | 12 weeks and 52 weeks | degree of fibrosis in meter per second (m/s) measured by Acoustic Radiation Force Impulse (ARFI) elastography |
| fat mass | 12 weeks and 52 weeks | fatt mass in kilogram (kg) measured by Bioelectrical Impedance Analysis (BIA) |
| Glutamate Pyruvate Transaminase (GPT) | 12 weeks and 52 weeks | Glutamate Pyruvate Transaminase in units/litre (U/L) |
| Gamma-glutamyltransferase (GGT) | 12 weeks and 52 weeks | Gamma-glutamyltransferase in units/litre (U/L) |
| insulin | 12 weeks and 52 weeks | insulin in micro units per millilitre (µU/ml) |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORStephan Martin, MD
West-German Centre of Diabetes and Health
Outcome results
None listed