Status:
COMPLETED
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
Lead Sponsor:
Johannes Gutenberg University Mainz
Collaborating Sponsors:
Goethe University
Conditions:
NASH - Nonalcoholic Steatohepatitis
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Effects of Wheat-based diet vs. ATI-free diet on NASH
Detailed Description
40 patients with the diagnosis of a non-alcoholic- steatohepatitis (NASH) will be recruited at the University Hospitals of Mainz and Frankfurt. Patients are assessed with regards to their diet using s...
Eligibility Criteria
Inclusion
- histologically proven NASH in the past 36 months with increased ALT: males: \>60, females: \>42 U/ml
- no body weight modification about \>10% in the past 24 weeks
- no new drugs treating parts of the metabolic syndrome in the past 12 weeks
- for patients with Diabetes: HbA1c value \<8,6%
- the ability to understand the aim and the possible individual consequences of this Trial
- signed and dated consent before the Trial starts
Exclusion
- unstable coronary heart disease, stroke in the past 6 months
- different liver diseases
- proceeded fibrosis (Fibroscan \>9,6 kPA) or histological cirrhosis
- hepatocellular carcinoma or not curative treated carcinomas
- alcohol consumption \>10g/day (females), \>20g/day (males)
- gravidity
- drugs causing secondary NASH (e.g. Tamoxifen, corticosteroids)
- immunological or inflammatory diseases (e.g. systemic Lupus erythematodes)
- warfarin therapy
- implementation of another Special diet
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04066400
Start Date
October 1 2018
End Date
December 27 2023
Last Update
December 28 2023
Active Locations (2)
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1
Universität Frankfurt
Frankfurt, Germany
2
University Medical Center Mainz
Mainz, Germany