The Impact of Bariatric Surgery on Non-alcoholic Fatty Liver Disease

NCT ID: NCT02828579

Last Updated: 2019-09-12

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-03-31

Brief Summary

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Up to 300 million people have a BMI over 30kg/m2. Obesity is the cause of many serious diseases, such as type 2 diabetes, hypertension and NAFLD. Bariatric surgery is the only effective method of achieving weight loss in patients with morbid obesity.

The aim of the study is to assess the impact of bariatric surgery on non-alcoholic fatty liver disease in patients operated on due to morbid obesity.

Detailed Description

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Investigators include 20 patients qualified for the bariatric procedure with BMI \> 40 kg/m2 or a BMI \> 35kg/m2 with the presence of comorbidities. The average body weight in the group was 143.85kg with an average BMI of 49.16kg/m2. Before the procedure, investigators evaluated the severity of the non-alcoholic fatty liver disease in each patient using the Sherif Saadeh ultrasound scale. Investigators also evaluated the levels of the liver enzymes. Follow up was performed twelve months after surgery.

Conditions

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Obesity NAFLD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patient with morbid obesity defined as a BMI above 40kg/m2 or 35kg/m2 with comorbidities who are qualified for bariatric surgery.

Bariatric surgery

Intervention Type PROCEDURE

Laparoscopic Sleeve Gastrectomy (LSG) Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)

Interventions

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Bariatric surgery

Laparoscopic Sleeve Gastrectomy (LSG) Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients at the age of 18-60, meeting the criteria of qualification for the surgical treatment of obesity, i.e. BMI \> 40 kg/m2 or BMI \> 35 kg/m2 together with accompanying diseases.

Exclusion Criteria

* chronic mental diseases
* addictions
* earlier bariatric procedures
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Michał Pędziwiatr

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Piotr Major, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

2'nd Department of General Surgery, Jagiellonian University Medical College

References

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Pirvulescu I, Gheorghe L, Csiki I, Becheanu G, Dumbrava M, Fica S, Martin S, Sarbu A, Gheorghe C, Diculescu M, Copaescu C. Noninvasive clinical model for the diagnosis of nonalcoholic steatohepatitis in overweight and morbidly obese patients undergoing bariatric surgery. Chirurgia (Bucur). 2012 Nov-Dec;107(6):772-9.

Reference Type RESULT
PMID: 23294957 (View on PubMed)

Saadeh S, Younossi ZM, Remer EM, Gramlich T, Ong JP, Hurley M, Mullen KD, Cooper JN, Sheridan MJ. The utility of radiological imaging in nonalcoholic fatty liver disease. Gastroenterology. 2002 Sep;123(3):745-50. doi: 10.1053/gast.2002.35354.

Reference Type RESULT
PMID: 12198701 (View on PubMed)

Picot J, Jones J, Colquitt JL, Gospodarevskaya E, Loveman E, Baxter L, Clegg AJ. The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation. Health Technol Assess. 2009 Sep;13(41):1-190, 215-357, iii-iv. doi: 10.3310/hta13410.

Reference Type RESULT
PMID: 19726018 (View on PubMed)

Fan JG, Zhu J, Li XJ, Chen L, Lu YS, Li L, Dai F, Li F, Chen SY. Fatty liver and the metabolic syndrome among Shanghai adults. J Gastroenterol Hepatol. 2005 Dec;20(12):1825-32. doi: 10.1111/j.1440-1746.2005.04058.x.

Reference Type RESULT
PMID: 16336439 (View on PubMed)

Promrat K, Kleiner DE, Niemeier HM, Jackvony E, Kearns M, Wands JR, Fava JL, Wing RR. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Hepatology. 2010 Jan;51(1):121-9. doi: 10.1002/hep.23276.

Reference Type RESULT
PMID: 19827166 (View on PubMed)

Other Identifiers

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JagiellonianU-04

Identifier Type: -

Identifier Source: org_study_id

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