Pathogenesis of Non-alcoholic Steatohepatitis and Liver R... | NCT02792634

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

NCT02792634

Sponsor

RWTH Aachen University

Status

Unknown status

Last Update Posted

Oct 25, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Bariatric Surgery Candidate
Nonalcoholic Steatohepatitis
Obesity

Interventions

Sleeve-Gastrectomy, Roux en Y gastric bypass

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Mar 22, 2016

First Submission Date that Met QC Criteria

Jun 1, 2016

First Posted Date

Jun 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2016

Last Update Posted Date

Oct 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
Sleeve-Gastrectomy, Roux en Y gastric bypass	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight in kg		24 month

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 years
scheduled for bariatric surgery
informed consent

Exclusion Criteria:

pregnancy
substance abuse
liver disease other than NASH

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

BMI > 35 kg/m2 Age > 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Kroh, MD	Contact	+49 (0)241 80	35478	akroh@ukaachen.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, University Hospital Aachen	Recruiting	Aachen	North Rhine-Westphalia	52074	Germany

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D009765	Obesity

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D050177	Overweight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015390	Gastric Bypass

Ancestor Terms

ID	Term
D050110	Bariatric Surgery
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided