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
|Condition or disease||Intervention/treatment||Phase|
|Non-Alcoholic Fatty Liver Disease Metabolic Encephalopathy Obesity, Morbid Non-alcoholic Steatohepatitis||Procedure: Bariatric surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
- 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.
- 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.
- 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.
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
|Contact: Mette M Lauridsen, MD PhDemail@example.com|
|Principal Investigator:||Mette M Lauridsen, MD, PhD||Hospital of South West Jutland|