ABCG8, UGT1A1 and Gallstone Disease After Bariatric Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEsbjerg Hospital - University Hospital of Southern Denmark
About this trial
The goal of this observational genetic case-control study is to learn whether two specific genetic variants in ABCG8 and UGT1A1 are associated with gallstone disease after bariatric surgery. The study includes adults who have previously undergone bariatric surgery.
The main questions it aims to answer are whether the ABCG8 D19H variant and the UGT1A1 rs6742078 variant are associated with an increased risk of gallstone disease requiring cholecystectomy after bariatric surgery.
Researchers will compare patients who underwent bariatric surgery and later had their gallbladder removed because of gallstone disease with patients who underwent bariatric surgery but did not develop gallstone disease or undergo cholecystectomy during follow-up.
Participants will provide one blood sample for targeted genetic analysis and complete questionnaires about health, previous surgery, medication use, family history, and gastrointestinal quality of life. Relevant clinical information will also be collected from medical records.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Bariatric surgery
Disqualifiers
Gallstone disease or cholecystectomy prior to bariatric surgery
Trial population
Adults who previously underwent bariatric surgery in the Region of Southern Denmark will be included. The study population consists of two groups: cases and controls. Cases are patients who underwent bariatric surgery and subsequently underwent cholecystectomy due to gallstone disease. Controls are patients who underwent bariatric surgery and have had at least five years of follow-up without registered gallstone disease or cholecystectomy. All participants will be identified through hospital records in the Region of Southern Denmark. Participants will provide a blood sample for targeted genetic analysis of selected variants in ABCG8 and UGT1A1 and complete questionnaires on health, medication use, family history, and gastrointestinal quality of life.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
blood sampling
Diagnostic testTargeted genetic analysis of the ABCG8 D19H variant and the UGT1A1 rs6742078 variant using a blood sample.
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: Bariatric surgery and subsequently cholecystectomy for gallstone disease1 intervention
Group B: Bariatric surgery and no gallstone disease1 intervention
Trial outcomes
Primary outcomes
1
ABCG8 carrier status
The primary outcome is the association between ABCG8 D19H carrier status and gallstone-related cholecystectomy after bariatric surgery. Cases are participants who underwent bariatric surgery and subsequently underwent cholecystectomy due to gallstone disease. Controls are participants who underwent bariatric surgery and did not undergo cholecystectomy or develop gallstone disease during follow-up. The association will be estimated by comparing genotype frequencies between cases and controls.
Time frame
3 yearsSecondary outcomes
1
Association Between UGT1A1 rs6742078 Carrier Status and Gallstone-Related Cholecystectomy After Bariatric Surgery
Association between UGT1A1 rs6742078 carrier status and gallstone-related cholecystectomy after bariatric surgery, estimated by comparing genotype frequencies between cases and controls.
Time frame
3 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Esbjerg Hospital - University Hospital of Southern Denmark
Lead sponsor
Odense University Hospital
Collaborator
University of Southern Denmark
Collaborator
Source ClinicalTrials.gov
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