Pathogenesis of Non-alcoholic Steatohepatitis and Liver Regeneration After Bariatric Surgery

• Conditions: Nonalcoholic Steatohepatitis; Bariatric Surgery Candidate; Obesity

• Registration Number: NCT02792634
• Lead Sponsor: RWTH Aachen University

Brief Summary

Obesity and obesity related health problems are globally recognized as one of the major threats to public health. Bariatric surgery is the most effective and durable therapy option for obesity and the improvement of obesity related co-morbidities. "Non alcoholic steatohepatitis" (NASH) is an important comorbidity of obesity and improves after surgical intervention. In this study investigators try to enlighten the weight independent mechanism for the effects of bariatric surgery. Patients who are assigned to a bariatric procedure will be observed for at least 24 month. A liver and adipose tissue samples are gained during the operation. Liver function and morphology are observed before and after operation with LiMAx, FibroScan and ultrasound. Systemic inflammation is measured in blood samples before and after surgical intervention. In order to check the microbiome stool samples are collected throughout the entire observation period.

Detailed Description

Every patient who is scheduled for bariatric surgery in the university hospital Aachen will be evaluated for this study. After informed consent baseline measurements are performed preoperative. Baseline measurements involve blood and stool samples, LiMAx, FibroScan and ultrasound. During the operation a liver, a subcutaneous and visceral fat sample are taken to analyse liver histology and inflammation as well as fatty tissue signaling. After the operation patients are observed 24 month. Further blood samples are taken on the first postoperative day, 2 and 4 weeks, 3, 6, 12, 18 and 24 month after the operation. Stool samples are taken 2 and 4 weeks, 3, 6, 12, 18 and 24 month after the intervention. The LiMAx test, a test analysing the liver function, is performed 4 weeks, 6, 12 and 24 month after the operation. The morphologic liver structure is evaluated by FibroScan and ultrasound 4 weeks, 6, 12 and 24 month postoperative.

Study Timeline

• Study First Submitted: 2016-03-22
• Status Verified: 2016-05
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-07
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25
• Primary Completion: 2020-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• >18 years
• scheduled for bariatric surgery
• informed consent

Exclusion Criteria

• pregnancy
• substance abuse
• liver disease other than NASH

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight in kg	24 month

Secondary Outcome Measures

Name	Time	Method
NAFLD (Non-alcoholic fatty liver disease) Activity Score (NAS)	within 7 days after the operation	The NAS will be assessed by a trained pathologist in a liver sample which is taken during the operation. The NAS usually will be assessed within 7 days after the Operation. The NAS is the basis for further clinical and laboratory tests and follow-up.

Trial Locations

Locations (1)

Department of Surgery, University Hospital Aachen; 🇩🇪 Aachen, NRW, Germany