An observational study in Gallstone Disease, Bariatric Surgery and Metabolic Surgery, sponsored by Esbjerg Hospital - University Hospital of Southern Denmark. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Esbjerg Hospital - University Hospital of Southern Denmark · Observational
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.
189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.
This study's planned enrollment of 270 is above the median of 197 across 50 observational studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →Esbjerg Hospital - University Hospital of Southern Denmark is the lead sponsor of 50 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
The case group. 135 patients.
Diagnostic Test: blood sampling
Control group. A minimum of 5 years of follow up after bariatric surgery.
Diagnostic Test: blood sampling
Targeted genetic analysis of the ABCG8 D19H variant and the UGT1A1 rs6742078 variant using a blood sample.
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 years
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 years
No study locations are listed for this record.
Plan to share: No — Small study. Individual participant data will not be shared due to the sensitive nature of genetic and clinical data and restrictions under Danish data protection regulations. Aggregated results can be shared in publications and upon reasonable request, where legally and ethically permissible.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Esbjerg Hospital - University Hospital of Southern Denmark