Prognostic Significance of Fatty Liver Disease in Bariatric Patients

Non-Alcoholic Fatty Liver Disease Clinical Trial

— PROMETHEUS  

Official title:

Prognostic Significance of Fatty Liver Disease in Bariatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03535142
• Other study ID #: S-20170210
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: April 1, 2038

Study information

• Verified date: September 2023
• Source: Hospital of South West Jutland
• Contact: Mette M Lauridsen, MD PhD
• Phone: +4579182000
• Email: mette.enok.munk.lauridsen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: April 1, 2038
• Est. primary completion date: June 1, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Fatty Liver
• Liver Diseases
• Metabolic Encephalopathy
• Non-Alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis
• Obesity, Morbid

Intervention

Procedure:
• Bariatric surgery
Roux en y gastric bypass or gastric sleeve operation

Locations

Country	Name	City	State
Denmark	Hospital of Southwest Jutland	Esbjerg

Sponsors (3)

Lead Sponsor	Collaborator
Hospital of South West Jutland	Odense University Hospital, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who will die during the follow up period in case and control group	Difference in mortality between cases and controls with various NAFLD severity on biopsy.	10 years follow up after inclusion
Secondary	Number of participant who will experience progressive fatty liver disease in case and control group	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	10 years follow up after inclusion
Secondary	Change in continuous reaction time measurement after bariatric surgery	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.	10 years follow up after inclusion
Secondary	Change in EEG after bariatric 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.	24 months after surgery
Secondary	Change in intelligence quotient after bariatric surgery	Measured by Weschlers adult intelligence scale (WAIS). An IQ if 100 i the norm. Range 50-150.	24 months efter surgery