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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828579
• Other study ID #: JagiellonianU-04
• Status: Completed
• Start date: February 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2019
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Obesity

Intervention

Procedure:
• Bariatric surgery
Laparoscopic Sleeve Gastrectomy (LSG) Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

References & Publications (5)

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. — View Citation

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 — View 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 ba — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NAFLD	Ultrasound assessment of the severity of NAFLD with the Sherif-Saadeh scale.	12 months
Secondary	Weight loss after bariatric surgery	Excess Body Mass Index loss (EBMIL)	12 months after surgery
Secondary	Comorbidities	Number of patients with hypertension and diabetes	12 months after surgery
Secondary	Liver function impairment	Standard set of blood liver enzymes including aspartate aminotransferase (AST) and alanine aminotransferase (ALT)	12 months after surgery