Bariatric Surgery Candidate Clinical Trial
Official title:
Intestinal Permeability in Patients With Liver Fibrosis and NASH Progression Undergoing Bariatric-metabolic Surgery
NCT number | NCT05257200 |
Other study ID # | 2180/2020 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2021 |
Est. completion date | December 2025 |
Verified date | March 2024 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Increased intestinal permeability and dysbiosis have been causally associated with NAFLD and NASH progression. However, to date, there are no systematic studies, on the effect of bariatric-metabolic surgery on intestinal permeability and dysbiosis in the context of NAFLD development.
Status | Recruiting |
Enrollment | 125 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with morbid obesity undergoing bariatric metabolic surgery according to the IFSO criteria, - Willingness to attend all follow-up visits - Written consent Exclusion Criteria: - other liver disease than NAFLD - presence of IBD, acute pancreatitis, amyotrophic lateral sclerosis, pregnancy |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intestinal Permeability improves with significant weight loss after bariatric metabolic surgery | At the time of surgery and 12 months after surgery a multisugar (lactulose-mannitol) test will be performed, stool and blood samples will be taken. During surgery small bowel biopsies and liver biopsies will be taken. For the 12 months visit noninvasive fibrosis markers will be calculated, transient elastography will be performed and compared to the results from the intestinal permeability assays.
Analysis will be performed on anonymized data only. A list cross-linking the patient number to the name will be kept secure and is only available to the principal researcher. Written informed consent will be kept for 15 years. Missing data will not be imputed but reported upon in the results. |
12 months observation period | |
Primary | Refractory fibrosis or fibrosis progression after bariatric surgery is associated with persistent intestinal permeability | At the time of surgery and 12 months after surgery a multisugar (lactulose-mannitol) test will be performed, stool and blood samples will be taken. During surgery small bowel biopsies and liver biopsies will be taken. For the 12 months visit noninvasive fibrosis markers will be calculated, transient elastography will be performed and compared to the results from the intestinal permeability assays.
Analysis will be performed on anonymized data only. A list cross-linking the patient number to the name will be kept secure and is only available to the principal researcher. Written informed consent will be kept for 15 years. Missing data will not be imputed but reported upon in the results. |
12 months observation period |
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