- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501042
Investigation on the Role of Gut-liver Axis for Non-alcoholic Steatohepatitis Through Bariatric Surgery
Investigation on Novel Route of Gut Microbiota Products for Bariatric Surgery to Improve Non-alcoholic Steatohepatitis and Development on Therapeutic Implications
Study Overview
Status
Intervention / Treatment
Detailed Description
The investigators anticipate to recruit 140 morbidly obese patients who will receive bariatric surgery including 100 patients receiving sleeve gastrectomy (SG) and 40 receiving gastric bypass surgery (GB). Liver biopsy will be performed during the operation to confirm the histological scores of NAFLD severity. The investigators expect to have 50% NASH and 50% NAFL patients from these morbidly obese patients based on previous domestic data. (i.e. 50 patients receiving SG to have NASH and 50 patients receiving SG to have NAFL; 20 patients receiving GB to have NASH and 20 patients receiving GB to have NAFL.) In this study, the investigators have two study objectives which are as follows.
- The first objective is to discover potential mechanisms among gut-liver axis for preventing or promoting NAFL to NASH by comparing (1) fecal microbiome composition and metabolomics, (2) peripheral blood biochemistry, metabolomics, immune cell phenotypes, and cytokines (3) portal vein biochemistry, metabolomics, immune cell phenotypes, and cytokines (4) Liver metabolomics and RNA-seq (5) gut permeability test (lactulose/mannitol challenge) (6) host genetic susceptibility for NAFLD (PNPLA3 and TM6SF2) between the tissue-proved NASH and NAFL patients in this study with a cross-sectional comparison.
- The second objective is to longitudinally investigate the potential mechanisms of bariatric surgery for improving NASH via a gut-microbiota dependent pathway. Clinical and experimental data before (baseline) and after (1st, 3rd, 6th months) bariatric surgery will be collected which include (1) non-invasive evaluation of NAFLD severity (Fibroscan, MRI-PDFF (proton density fat fraction) and MRE), (2) blood biochemistry, metabolomics, immune cell phenotypes, and cytokines (3) fecal microbiome and metabolomics (4) gut permeability test (5) liver biopsy histology (if available)
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Wei-Kai Wu
- Phone Number: +886-2-23717101
- Email: weikaiwu0115@gmail.com
Study Locations
-
-
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Ming-Shiang Wu, MD, PhD
- Phone Number: 65043 +886-2-23123456
- Email: mingshiang@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Age >20,morbidly obese patients who will receive bariatric surgery.
Exclusion Criteria:
- Average daily alcohol intake >20 grams,
- Hepatitis B carriers, Hepatitis C carriers,
- people with liver disease caused by other causes
- liver cirrhosis,
- diseases related to abnormal blood coagulation,
- inflammatory bowel disease,
- routine use of steroids or immunity Inhibitors and other immunomodulatory drugs
- ursodeoxycholic and other drugs that affect bile acid metabolism
- those who have used antibiotics or probiotics within one month
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obese patients tissue proved NASH
age >20,morbid obesity who will receive bariatric surgery, tissue proved NASH
|
|
Obese patients tissue proved NAFL
age >20,morbid obesity who will receive bariatric surgery, tissue proved NAFL
|
|
NASH (before bariatric surgery)
age >20,morbid obesity receiving bariatric surgery and was proved NASH histologically.
Data collected before bariatric surgery.
|
Bariatric surgery
Other Names:
|
NASH (after bariatric surgery)
age >20,morbid obesity receiving bariatric surgery and was proved NASH histologically.
Data collected after bariatric surgery.
|
Bariatric surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of NAFLD severity score (histology) from baseline to the 6th month
Time Frame: Baseline and 6 months after bariatric surgery
|
Liver biopsy will be performed before and after surgery (if available) to acquire histology evaluation
|
Baseline and 6 months after bariatric surgery
|
Change of NAFLD severity measured by Fibroscan from baseline to the 6th month
Time Frame: Baseline and 6 months after bariatric surgery
|
Fibroscan (CAP and kPa)
|
Baseline and 6 months after bariatric surgery
|
Change of NAFLD severity measured by MRI proton density fat fraction from baseline to the
Time Frame: Baseline and 6 months after bariatric surgery
|
MRI proton density fat fraction (%)
|
Baseline and 6 months after bariatric surgery
|
Change of NAFLD severity measured by magnetic resonance elastography from baseline to the
Time Frame: Baseline and 6 months after bariatric surgery
|
magnetic resonance elastography (kPa)
|
Baseline and 6 months after bariatric surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of gut microbiome profiles
Time Frame: Baseline, 1st month, 3rd month and 6th month after surgery
|
fecal 16S ribosomal RNA sequencing and shotgun metagenome sequencing
|
Baseline, 1st month, 3rd month and 6th month after surgery
|
Change of body fluid metabolomic profiles
Time Frame: Baseline, 1st month, 3rd month and 6th month after surgery
|
Metabolites in blood fluids measured by liquid chromatography mass spectrometry
|
Baseline, 1st month, 3rd month and 6th month after surgery
|
Change of Immune profiles
Time Frame: Baseline, 1st month, 3rd month and 6th month after surgery
|
Immune cell phenotype patterns in body fluids measured by flow cytometry
|
Baseline, 1st month, 3rd month and 6th month after surgery
|
Change of gut permeability test
Time Frame: Baseline and 6 months after bariatric surgery
|
Lactulose/Mannitol challenge test
|
Baseline and 6 months after bariatric surgery
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Change of gene expression profiles of liver tissue
Time Frame: Baseline and 6 months after bariatric surgery (if available)
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gene expression measured by RNA-seq
|
Baseline and 6 months after bariatric surgery (if available)
|
Change of metabolomic profiles of liver tissue
Time Frame: Baseline and 6 months after bariatric surgery (if available)
|
Metabolites in liver tissue measured by liquid chromatography mass
|
Baseline and 6 months after bariatric surgery (if available)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ming-Shiang Wu, MD, PhD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201903037RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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