Bariatric Surgery on NASH

NCT04043585 | Completed DMC

• 1 other identifier: EBSoNAS
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Obesity

Outcome Measures

Primary Outcomes (1)

• NAFLD activity score

  Change in NAFLD activity score (NAS). Assessment of NAS, a standardized tool for assessment of liver histology, is often used for quantification of disease activity, allowing comparison of biopsies in clinical studies and improved reproducibility. The NAS is defined as the sum of scores for steatosis (0-3), lobular inflammation (0-3) and ballooning degeneration (0-2)

  18 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

30-40 patients referred to laparoscopic bariatric surgery (either RYGB or SG)

You may qualify if:

• Obese (BMI≥35 kg/m2) individuals referred for bariatric surgery, either RYGB or SG
• Evidence of potential NASH with fibrosis
• Willing to give informed consent and comply with all study procedures

You may not qualify if:

• Type 1 diabetes
• 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.

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Gubra ApS: collaborator

Study Sites (1)

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsies for histological and transcriptomic assessment

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip K Knop, MD, PhD

  UGGentofte

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of department

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: July 31, 2019
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

DK (1)