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

NCT ID: NCT02792634

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Candidate Nonalcoholic Steatohepatitis Obesity

Keywords

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Bariatric surgery Nonalcoholic Steatohepatitis Obesity

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Sleeve-Gastrectomy, Roux en Y gastric bypass

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* substance abuse
* liver disease other than NASH
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Surgery, University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andreas Kroh, MD

Role: CONTACT

Phone: +49 (0)241 80

Email: [email protected]

Facility Contacts

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Andreas Kroh, MD

Role: primary

Other Identifiers

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15-164

Identifier Type: -

Identifier Source: org_study_id