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NCT Number: NCT03535142

Prognostic Significance of Fatty Liver Disease in Bariatric Patients

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Body Weight Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fatty Liver Liver Diseases Metabolic Diseases Metabolic Encephalopathy Nervous System Diseases Non-alcoholic Steatohepatitis Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Southwest Jutland

Esbjerg, 6700, Denmark

Location status: Recruiting

Location contact

Mette Lauridsen, Postdoc

CONTACT

[email protected]

61661192

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

Roux en y gastric bypass or gastric sleeve operation

Primary outcomes

  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 outcomes

  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:

    • Grade 1 steatosis
    • Grade 2 steatosis
    • Grade 3 steatosis
    • Non alcoholic steatohepatitis
    • Presence of fibrosis Kleiner grade 1-2
    • Presence of fibrosis Kleiner grade 3
    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mette M Lauridsen, MD PhD

CONTACT

[email protected]

4579182000

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • Esbjerg University Hospital of South-West Jutland
  • Odense University Hospital
  • University of Southern Denmark

Registry information

Acronym: PROMETHEUS

Important dates

Study start
2018
Primary completion
2035
Study completion
2038
First posted
May 24, 2018
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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