Obesity Clinical Trial - Pathogenesis of Non-alcoholic Steatohepatitis &

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02792634
Study type	Observational
Source	RWTH Aachen University
Contact	Andreas Kroh, MD
Phone	+49 (0)241 80
Email	akroh@ukaachen.de
Status	Recruiting
Phase	N/A
Start date	June 2016
Completion date	December 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms