Clinical trial NCT02792634: Pathogenesis of Non-alcoholic Steatohepatitis and Liver Regeneration After Bariatric Surgery
Official title: Pathogenesis of Non-alcoholic Steatohepatitis and Liver Regeneration After Bariatric Surgery / Untersuchung Der Pathogenese Der Nicht-alkoholischen Steatohepatitis Und Der Leberregeneration Nach Bariatrischer Chirurgie
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery Candidate
Nonalcoholic Steatohepatitis
Obesity
Keywords: Bariatric surgery
Nonalcoholic Steatohepatitis
Obesity
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BMI \> 35 kg/m2 Age \> 18 years

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.

Eligibility criteria: Inclusion Criteria:

* \>18 years
* scheduled for bariatric surgery
* informed consent

Exclusion Criteria:

* pregnancy
* substance abuse
* liver disease other than NASH

Primary outcomes:
measure: Weight in kg
timeFrame: 24 month
Secondary outcomes:
measure: NAFLD (Non-alcoholic fatty liver disease) Activity Score (NAS)
timeFrame: within 7 days after the operation
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Surgery, University Hospital Aachen
state: NRW
Study officials:
References: