Status:
COMPLETED
Bariatric Surgery on NASH
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborating Sponsors:
Gubra ApS
Conditions:
Non-Alcoholic Fatty Liver Disease
Obesity
Eligibility:
All Genders
18-60 years
Brief Summary
The study investigates non-alcoholic fatty liver disease from serial liver biopsies collected from participants referred for assessment of bariatric surgery, RYGB or SG.
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is an increasing health care problem closely related to obesity and has become the most common cause of chronic liver disease in developed countries. Today, b...
Eligibility Criteria
Inclusion
- Obese (BMI≥35 kg/m2) individuals referred for bariatric surgery, either RYGB or SG
- Age between 18 and 60 years at the time of inclusion
- Evidence of potential NASH with fibrosis
- Willing to give informed consent and comply with all study procedures
Exclusion
- Type 1 diabetes
- Alcohol consumption ≥20 g/day for women or ≥30 g/day for men over a two-year period prior to inclusion
- Clinically significant kidney function impairment or other laboratory findings at time of screening leading to the diagnosis of clinically relevant disorders
- Any physical or psychological condition that the investigator evaluates would interfere with trial participation
- Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
- Planned elective surgery (other than bariatric surgery) during the study period with the exception of dermatosurgical, ENT (ear, nose, throat) or dental procedures not requiring general anaesthesia and/or perioperative antibiotic treatment
- Pregnancy or desire to become pregnant during the study period
- Any ongoing medication that the investigator evaluates would interfere with trial participation including anticoagulant medication, and medication that could cause NAFLD
- Contraindications to liver biopsy
- Other causes of liver disease than NAFLD, including viral hepatitis, Wilsons disease, cystic fibrosis, coeliac disease and alpha-1 antitrypsin deficiency.
Key Trial Info
Start Date :
July 31 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 29 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04043585
Start Date
July 31 2019
End Date
March 29 2023
Last Update
November 29 2023
Active Locations (1)
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1
Center for Clinical Metabolic Research
Hellerup, Denmark, 2900