NCT02828579

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

July 7, 2016

Last Update Submit

September 10, 2019

Conditions

ObesityNAFLD

Keywords

obesitybariatric surgerynon-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

  • NAFLD

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

    12 months

Secondary Outcomes (3)

  • Weight loss after bariatric surgery

    12 months after surgery

  • Comorbidities

    12 months after surgery

  • Liver function impairment

    12 months after surgery

Study Arms (1)

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

Bariatric surgeryPROCEDURE

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

Group 1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • chronic mental diseases
  • addictions
  • earlier bariatric procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 23294957RESULT

  • 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.

    PMID: 12198701RESULT

  • 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.

    PMID: 19726018RESULT

  • 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.

    PMID: 16336439RESULT

  • 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.

    PMID: 19827166RESULT

MeSH Terms

Conditions

ObesityNon-alcoholic Fatty Liver Disease

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Piotr Major, MD, PhD

    2'nd Department of General Surgery, Jagiellonian University Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 11, 2016

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

data not entered