Clinical trial NCT02828579: The Impact of Bariatric Surgery on Non-alcoholic Fatty Liver Disease
Official title: The Impact of Bariatric Surgery on Non-alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
NAFLD
Keywords: obesity
bariatric surgery
non-alcoholic fatty liver disease
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The analysis included prospectively collected data from consecutive patients electively operated for morbid obesity in 2015.

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.

Eligibility criteria: 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

Primary outcomes:
measure: NAFLD
timeFrame: 12 months
Secondary outcomes:
measure: Weight loss after bariatric surgery
timeFrame: 12 months after surgery
measure: Comorbidities
timeFrame: 12 months after surgery
measure: Liver function impairment
timeFrame: 12 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: 2'nd Department of General Surgery, Jagiellonian University Medical College
name: Piotr Major, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.