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Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease

NCT ID: NCT01828528

Last Updated: 2016-11-28

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

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and after bariatric surgery. The investigators also aim to study the short-term effect of bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric surgery.

Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

Keywords

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Nonalcoholic fatty liver disease Nonalcoholic steatohepatitis Obesity Bariatric surgery Weight loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NAFLD after SG

26 patients with NAFLD undergoing sleeve gastrectomy (SG).

Sleeve gastrectomy

Intervention Type PROCEDURE

An intra-operative liver biopsy was performed in 20 patients

Interventions

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Sleeve gastrectomy

An intra-operative liver biopsy was performed in 20 patients

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 20≤ age ≤80
* BMI\>35kg/m2
* Men and women
* Fatty infiltration in liver ultrasonography

Exclusion Criteria

* Alcohol drinking \> 140g/week
* Presence of hepatitis B or C or HIV
* Known liver disease such as:

1. Wilson's disease
2. hemochromatosis
3. α1-antitrypsin deficiency
4. autoimmune liver disease
5. primary biliary cirrhosis
6. primary sclerosing cholangitis)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ziv Ben-Ari, Prof

Role: PRINCIPAL_INVESTIGATOR

Director Liver Disease Center, Sheba Medical Center, Tel-Hashomer, Israel

Locations

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Liver Disease Center, Sheba Medical Center, Tel-Hashomer

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-12-0026-ZB-CTIL

Identifier Type: -

Identifier Source: org_study_id