NCT04569396

Brief Summary

The study is based on data from morbidly obese patients who fulfilled the criteria for bariatric surgery during 2016-2018 at the Department of Surgery, University Hospital Ostrava, Czech Republic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 12, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

2.9 years

First QC Date

September 23, 2020

Last Update Submit

September 30, 2020

Conditions

Morbid ObesityDiabetesHypertension

Keywords

non-alcoholic fatty liver diseasebariatric surgeryobesityliver fibrosis

Outcome Measures

Primary Outcomes (5)

  • Biochemistry analysis

    Biochemistry analysis of liver parameters were analyzed among the study subjects before and after the surgery (for details please see the Detailed description of the study)

    1 year

  • Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score

    NAFLD fibrosis score was determined among the study subjects before and after the surgery.

    1 year

  • BMI measurement

    BMI was measured among the study subjects before and after the surgery.

    1 year

  • Fibrosis 4 Index

    Fibrosis 4 Index was determined among the study subjects before and after the surgery.

    1 year

  • Fatty Liver Index

    Fatty Liver Index was determined among the study subjects before and after the surgery.

    1 year

Study Arms (1)

Non-Alcoholic Fatty Liver Disease

A total of 72 severely or morbidly obese patients with non-alcoholic fatty liver disease and associated co-morbidities like diabetes and hypertension were enrolled into the study.

Diagnostic Test: Biochemistry analysisDiagnostic Test: NAFLD fibrosis scoreOther: BMI measurementDiagnostic Test: Fibrosis 4 IndexDiagnostic Test: Fatty Liver Index

Interventions

Biochemistry analysisDIAGNOSTIC_TEST

Biochemistry analysis of liver parameters were analyzed among the study subjects before and after the surgery.

Non-Alcoholic Fatty Liver Disease
NAFLD fibrosis scoreDIAGNOSTIC_TEST

NAFLD fibrosis score was determined among the study subjects before and after the surgery.

Non-Alcoholic Fatty Liver Disease
BMI measurementOTHER

BMI was measured among the study subjects before and after the surgery.

Non-Alcoholic Fatty Liver Disease
Fibrosis 4 IndexDIAGNOSTIC_TEST

Fibrosis 4 Index was determined among the study subjects before and after the surgery.

Non-Alcoholic Fatty Liver Disease
Fatty Liver IndexDIAGNOSTIC_TEST

Fatty Liver Index was determined among the study subjects before and after the surgery.

Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with age above 18 years, BMI \> 35-40 kg/m2 and associated with at least one of the complications including hypertension, diabetes and failure of the current therapies to relive the symptoms were included in the study. Patients included in the current study does not have a history of excessive alcohol consumption, use of hepatotoxic drugs, infectious liver diseases (i.e. hepatitis A, B, C) and genetic hemochromatosis.

You may qualify if:

  • age 18 years and above
  • BMI \> 35-40 kg/m2
  • hypertension or diabetes or failure of the current therapies to relive the symptoms

You may not qualify if:

  • history of excessive alcohol consumption
  • use of hepatotoxic drugs
  • infectious liver diseases (i.e. hepatitis A, B, C)
  • genetic hemochromatosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (1)

  • Toman D, Vavra P, Jelinek P, Ostruszka P, Ihnat P, Foltys A, Pelikan A, Roman J. Effect of bariatric surgery on fatty liver disease in obese patients: A prospective one year follow-up study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 May;166(2):195-203. doi: 10.5507/bp.2021.021. Epub 2021 Apr 19.

    PMID: 33885048DERIVED

MeSH Terms

Conditions

Obesity, MorbidDiabetes MellitusHypertensionNon-alcoholic Fatty Liver DiseaseObesityLiver Cirrhosis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesFatty LiverLiver DiseasesDigestive System DiseasesFibrosisPathologic Processes

Study Officials

  • Daniel Toman, MD

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 29, 2020

Study Start

January 12, 2016

Primary Completion

December 16, 2018

Study Completion

December 16, 2019

Last Updated

October 5, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will be made available to other researchers upon request.

Locations

CZ(1)