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CompletedNCT02828579Updated Sep 12, 2019

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

An observational study in Obesity and NAFLD, sponsored by Jagiellonian University. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by Jagiellonian University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Obesity
  • NAFLD

Keywords

  • obesity
  • bariatric surgery
  • non-alcoholic fatty liver disease
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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 20 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The analysis included prospectively collected data from consecutive patients electively operated for morbid obesity in 2015.

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

Exclusion Criteria:

  • chronic mental diseases
  • addictions
  • earlier bariatric procedures
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

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

    Procedure: Bariatric surgery

Interventions

  • ProcedureBariatric surgery

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

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What researchers measure

Primary outcomes

  1. NAFLD

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

    Time frame: 12 months

Secondary outcomes

  1. Weight loss after bariatric surgery

    Excess Body Mass Index loss (EBMIL)

    Time frame: 12 months after surgery

  2. Comorbidities

    Number of patients with hypertension and diabetes

    Time frame: 12 months after surgery

  3. Liver function impairment

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

    Time frame: 12 months after surgery

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 23294957 ↗
  • 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. PubMed 12198701 ↗
  • 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;13(41):1-190, 215-357, iii-iv. doi: 10.3310/hta13410. PubMed 19726018 ↗
  • 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. doi: 10.1111/j.1440-1746.2005.04058.x. PubMed 16336439 ↗
  • 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. PubMed 19827166 ↗

Individual participant data

Plan to share: No — data not entered

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02828579
Lead sponsor
Jagiellonian University
Responsible party
Michał Pędziwiatr (MD, PhD, Jagiellonian University) — Principal investigator
First posted
Jul 11, 2016
Start date
Feb 2015
Primary completion
Jan 2016
Completion
Mar 2016
Last update
Sep 12, 2019

Study contacts

Piotr Major, MD, PhD
principal investigator · 2'nd Department of General Surgery, Jagiellonian University Medical College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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