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

Completed

• Conditions: Obesity; NAFLD
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT02828579
• Lead Sponsor: Jagiellonian University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-11
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Bariatric surgery	Patient with morbid obesity defined as a BMI above 40kg/m2 or 35kg/m2 with comorbidities who are qualified for bariatric surgery.

Primary Outcome Measures

Name	Time	Method
NAFLD	12 months	Ultrasound assessment of the severity of NAFLD with the Sherif-Saadeh scale.

Secondary Outcome Measures

Name	Time	Method
Comorbidities	12 months after surgery	Number of patients with hypertension and diabetes
Liver function impairment	12 months after surgery	Standard set of blood liver enzymes including aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
Weight loss after bariatric surgery	12 months after surgery	Excess Body Mass Index loss (EBMIL)