ABCG8, UGT1A1 and Gallstone Disease After Bariatric Surgery: A Genetic Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 270
- Primary Endpoint
- ABCG8 carrier status
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Bariatric surgery
Exclusion Criteria
- •Gallstone disease or cholecystectomy prior to bariatric surgery
Arms & Interventions
Bariatric surgery and no gallstone disease
Control group. A minimum of 5 years of follow up after bariatric surgery.
Intervention: blood sampling (Diagnostic Test)
Bariatric surgery and subsequently cholecystectomy for gallstone disease
The case group. 135 patients.
Intervention: blood sampling (Diagnostic Test)
Outcomes
Primary Outcomes
ABCG8 carrier status
Time Frame: 10 years
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.
ABCG8 carrier status
Time Frame: 3 years
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.
Secondary Outcomes
- Association Between UGT1A1 rs6742078 Carrier Status and Gallstone-Related Cholecystectomy After Bariatric Surgery(10 years)
- Association Between UGT1A1 rs6742078 Carrier Status and Gallstone-Related Cholecystectomy After Bariatric Surgery(3 years)
Investigators
Benjamin Drejer Petersen
M.D., PhD Fellow
Esbjerg Hospital - University Hospital of Southern Denmark