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Prognostic Significance of Fatty Liver Disease in Bariatric Patients (PROMETHEUS)

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ClinicalTrials.gov Identifier: NCT03535142
Recruitment Status : Not yet recruiting
First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Collaborators:
University of Southern Denmark
Odense University Hospital
Information provided by (Responsible Party):
Mette Munk Lauridsen, Hospital of South West Jutland

Brief Summary:
Prospective non-randomized intervention case control study on patients with a BMI > 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Metabolic Encephalopathy Obesity, Morbid Non-alcoholic Steatohepatitis Procedure: Bariatric surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prognostic Significance of Fatty Liver Disease in Bariatric Patients
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2035
Estimated Study Completion Date : April 1, 2038


Arm Intervention/treatment
Experimental: Intervention
The intervention is bariatric surgery (Roux en Y gastric bypass or gastric sleeve operation).
Procedure: Bariatric surgery
Roux en y gastric bypass or gastric sleeve operation

No Intervention: Control
Age, BMI and co-morbidity matched group who do not undergo surgery.



Primary Outcome Measures :
  1. Number of participants who will die during the follow up period in case and control group [ Time Frame: 10 years follow up after inclusion ]
    Difference in mortality between cases and controls with various NAFLD severity on biopsy.


Secondary Outcome Measures :
  1. Number of participant who will experience progressive fatty liver disease in case and control group [ Time Frame: 10 years follow up after inclusion ]

    Difference NAFLD severity between case and control group after 10 years follow up. Simple steatosis is the mildest form and liver cirrhosis is the most serious manifestation:

    1. Grade 1 steatosis
    2. Grade 2 steatosis
    3. Grade 3 steatosis
    4. Non alcoholic steatohepatitis
    5. Presence of fibrosis Kleiner grade 1-2
    6. Presence of fibrosis Kleiner grade 3
    7. Presence of liver cirrhosis

  2. Change in continuous reaction time measurement after bariatric surgery [ Time Frame: 10 years follow up after inclusion ]
    Continuous reaction time measurement will measure reaction time instability and is a measure of metabolic encephalopathy. The method is a 10-minutes, computerised registration of a series of motor reaction times to an auditory stimulus, with results reported as the CRTindex (50 percentile/(90-10) percentile) as a parameter of reaction time variability. A CRT index below 1.9 i considerede abnormal a may be a sign of hepatic encephalopathy.

  3. Change in EEG after bariatric surgery [ Time Frame: 24 months after surgery ]
    Change in mean dominant frequency(MD) on EEG spectral analysis. EEG disturbances in hepatic encephalopathy are (rated by severity)but there is no enough space here to describe it.

  4. Change in intelligence quotient after bariatric surgery [ Time Frame: 24 months efter surgery ]
    Measured by Weschlers adult intelligence scale (WAIS). An IQ if 100 i the norm. Range 50-150.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria case group:

  • Age > 18 years
  • BMI >35 kg/m2 and referred for bariatric surgery at Hospital of South West Jutland, Denmark
  • Able to give written informed consent.

Inclusion criteria control group:

  • Age > 18 years
  • BMI >35 kg/m2 with no wish to undergo bariatric surgery.
  • Able to give written informed consent.

Exclusion Criteria:

  • Active viral hepatitis
  • Not willing or able to consent
  • Contraindications to liver biopsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535142


Contacts
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Contact: Mette M Lauridsen, MD PhD +4579182000 mette.enok.munk.lauridsen@rsyd.dk

Sponsors and Collaborators
Hospital of South West Jutland
University of Southern Denmark
Odense University Hospital
Investigators
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Principal Investigator: Mette M Lauridsen, MD, PhD Hospital of South West Jutland

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Responsible Party: Mette Munk Lauridsen, Postdoc researcher, Hospital of South West Jutland
ClinicalTrials.gov Identifier: NCT03535142     History of Changes
Other Study ID Numbers: S-20170210
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Brain Diseases
Brain Diseases, Metabolic
Obesity, Morbid
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Metabolic Diseases