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

Obesity Clinical Trial

— NALKOSTEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02792634
• Other study ID #: 15-164
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2016
• Last updated: October 24, 2016
• Start date: June 2016
• Est. completion date: December 2022

Study information

• Verified date: May 2016
• Source: RWTH Aachen University
• Contact: Andreas Kroh, MD
• Phone: +49 (0)241 80
• Email: akroh[@]ukaachen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years

• scheduled for bariatric surgery

• informed consent

Exclusion Criteria:

• pregnancy

• substance abuse

• liver disease other than NASH

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis
• Obesity

Intervention

Procedure:
• Sleeve-Gastrectomy, Roux en Y gastric bypass

Locations

Country	Name	City	State
Germany	Department of Surgery, University Hospital Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight in kg		24 month	No
Secondary	NAFLD (Non-alcoholic fatty liver disease) Activity Score (NAS)	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.	within 7 days after the operation	No