Prognostic Significance of Fatty Liver Disease in Bariatric Patients

Not Applicable

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease; Obesity, Morbid; Non-alcoholic Steatohepatitis; Metabolic Encephalopathy

• Registration Number: NCT03535142
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-23
• Study First Posted: 2018-05-24
• Study Start: 2018-08-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2035-06-01
• Study Completion: 2038-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants who will die during the follow up period in case and control group	10 years follow up after inclusion	Difference in mortality between cases and controls with various NAFLD severity on biopsy.

Secondary Outcome Measures

Name	Time	Method
Change in continuous reaction time measurement after bariatric surgery	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.
Number of participant who will experience progressive fatty liver disease in case and control group	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
Change in EEG after bariatric surgery	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.
Change in intelligence quotient after bariatric surgery	24 months efter surgery	Measured by Weschlers adult intelligence scale (WAIS). An IQ if 100 i the norm. Range 50-150.

Trial Locations

Locations (1)

Hospital of Southwest Jutland; 🇩🇰 Esbjerg, Denmark