NASH - Nonalcoholic SteatohepatitisNCT05257200
Gut Permeability and Bariatric-metabolic Surgery
An observational study of NASH - Nonalcoholic Steatohepatitis and Bariatric Surgery Candidate, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis, Bariatric Surgery Candidate, Intestinal Permeability
- How many people
- 125 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2021to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with morbid obesity undergoing bariatric metabolic surgery according to the IFSO criteria,
- Willingness to attend all follow-up visits
- Written consent
Who cannot join
- other liver disease than NAFLD
- presence of IBD, acute pancreatitis, amyotrophic lateral sclerosis, pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Magdalena Mairinger, MD, PhD, 004314040056210, magdalena.mairinger@meduniwien.ac.at
Paula Richwien, MD, 004314040056210, paula.richwien@meduniwien.ac.at
About this study
Official title: Intestinal Permeability in Patients With Liver Fibrosis and NASH Progression Undergoing Bariatric-metabolic Surgery
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.
Read the 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.
- Keywords
- liver fibrosis, NAFLD, One Anastomosis Gastric Bypass, Roux-en-Y Gastric Bypass, Gut-liver axis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 May 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Prager, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257200
- Sponsor's protocol ID
- 2180/2020
- Status last verified
- Mar 2024
- First submitted
- 10 Jan 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Permeability in Patients With Liver Fibrosis and NASH Progression Undergoing Bariatric-metabolic Surgery
- ClinicalTrials.gov ID
- NCT05257200
- Acronym / sponsor ID
- 2180/2020
- Keywords
- liver fibrosis, NAFLD, One Anastomosis Gastric Bypass, Roux-en-Y Gastric Bypass, Gut-liver axis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with morbid obesity undergoing bariatric metabolic surgery according to the IFSO criteria,
- Willingness to attend all follow-up visits
- Written consent
Key exclusion criteria (2 listed)
- other liver disease than NAFLD
- presence of IBD, acute pancreatitis, amyotrophic lateral sclerosis, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intestinal Permeability improves with significant weight loss after bariatric metabolic surgery
Time frame: 12 months observation period
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.
Refractory fibrosis or fibrosis progression after bariatric surgery is associated with persistent intestinal permeability
Time frame: 12 months observation period
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
Related trials for NASH - Nonalcoholic Steatohepatitis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NASH - Nonalcoholic Steatohepatitis and Bariatric Surgery Candidate, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal Permeability improves with significant weight loss after bariatric metabolic surgery (time frame: 12 months observation period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.