Gut Permeability and Bariatric-metabolic Surgery

NCT05257200 | Recruiting

• 1 other identifier: 2180/2020
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• other liver disease than NAFLD
• presence of IBD, acute pancreatitis, amyotrophic lateral sclerosis, pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Bariatric Surgery

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 25, 2022
• Study Start: May 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

AU (1)