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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02828579

Enrollment

Registered

2016-07-11

Start date

2015-02-28

Completion date

2016-03-31

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD, Obesity

Keywords

obesity, bariatric surgery, non-alcoholic fatty liver disease

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.

Interventions

PROCEDUREBariatric surgery

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
NAFLD	12 months	Ultrasound assessment of the severity of NAFLD with the Sherif-Saadeh scale.

Secondary

Measure	Time frame	Description
Weight loss after bariatric surgery	12 months after surgery	Excess Body Mass Index loss (EBMIL)
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026