Clinical trial NCT05257200: Gut Permeability and Bariatric-metabolic Surgery
Official title: Intestinal Permeability in Patients With Liver Fibrosis and NASH Progression Undergoing Bariatric-metabolic Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NASH - Nonalcoholic Steatohepatitis
Bariatric Surgery Candidate
Intestinal Permeability
Keywords: liver fibrosis
NAFLD
One Anastomosis Gastric Bypass
Roux-en-Y Gastric Bypass
Gut-liver axis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In our patients about 80% have NAFLD, about 50-60% are diagnosed with NASH. Furthermore, we know from our obese patient cohort, that 26% are diagnosed with fibrosis grade 2 or higher. Only patients that are scheduled for weight loss surgery will be enrolled in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intestinal Permeability improves with significant weight loss after bariatric metabolic surgery
timeFrame: 12 months observation period
measure: Refractory fibrosis or fibrosis progression after bariatric surgery is associated with persistent intestinal permeability
timeFrame: 12 months observation period
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: