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Completed

NCT Number: NCT02828579

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

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.

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Key information

Conditions

Obesity Body Weight Digestive System Diseases Fatty Liver Liver Diseases NAFLD Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

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

Primary outcomes

  1. NAFLD

    Time frame: 12 months

    Ultrasound assessment of the severity of NAFLD with the Sherif-Saadeh scale.

Secondary outcomes

  1. Weight loss after bariatric surgery

    Time frame: 12 months after surgery

    Excess Body Mass Index loss (EBMIL)

  2. Comorbidities

    Time frame: 12 months after surgery

    Number of patients with hypertension and diabetes

  3. Liver function impairment

    Time frame: 12 months after surgery

    Standard set of blood liver enzymes including aspartate aminotransferase (AST) and alanine aminotransferase (ALT)

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2016
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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