Gut Permeability and Bariatric-metabolic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Morbid obesity is associated with non-alcoholic fatty liver disease (NAFLD) in 80-90% of patients, and non-alcoholic steatohepatitis (NASH) occurs in up to 60% of patients. If left untreated, the disease can progress to liver fibrosis, cirrhosis, or hepatocellular carcinoma. Weight loss of \>10% of body weight is the most effective treatment for NAFLD, and bariatric metabolic surgery plays an effective role in achieving long-term weight loss. About 80% of patients achieve improvement or reversal of NAFLD after bariatric-metabolic surgery. However, clinical and histological progression of liver disease may occur in about 20% of patients, despite weight the loss. Increased intestinal permeability and dysbiosis have been causally associated with NAFLD and NASH progression. However, to date, there are no systematic studies, on intestinal permeability and dysbiosis after bariatric-metabolic surgery.

Research questions

* To investigate the changes in intestinal permeability after bariatric-metabolic surgery.
* To investigate the differences in intestinal permeability at the time of surgery and 1 year after surgery between patients with liver fibrosis grades F≤1 and F≥2 (low-grade fibrosis vs advanced fibrosis).
* To investigate differences between patients with and without liver fibrosis progression using parameters for metabolic endotoxemia, intestinal permeability, and dysbiosis.

Conditions

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NASH - Nonalcoholic Steatohepatitis Bariatric Surgery Candidate Intestinal Permeability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with morbid obesity undergoing bariatric metabolic surgery according to the IFSO criteria,
* Willingness to attend all follow-up visits
* Written consent