ABCG8, UGT1A1 and Gallstone Disease After Bariatric Surgery

NCT07702630 | Not Yet Recruiting

• 1 other identifier: EsbjergH (ABCG8)
• Study Type: observational
• Target: 270
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gallstone Disease; Bariatric Surgery; Metabolic Surgery; Cholecystectomy; Genetics

Outcome Measures

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.

  3 years

Secondary Outcomes (1)

• Association Between UGT1A1 rs6742078 Carrier Status and Gallstone-Related Cholecystectomy After Bariatric Surgery

  3 years

Study Arms (2)

Bariatric surgery and subsequently cholecystectomy for gallstone disease

The case group. 135 patients.

Diagnostic Test: blood sampling

Bariatric surgery and no gallstone disease

Control group. A minimum of 5 years of follow up after bariatric surgery.

Diagnostic Test: blood sampling

Interventions

blood sampling DIAGNOSTIC_TEST

Targeted genetic analysis of the ABCG8 D19H variant and the UGT1A1 rs6742078 variant using a blood sample.

Bariatric surgery and no gallstone disease; Bariatric surgery and subsequently cholecystectomy for gallstone disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Bariatric surgery

You may not qualify if:

• Gallstone disease or cholecystectomy prior to bariatric surgery

Sponsors & Collaborators

• University of Southern Denmark: collaborator
• Odense University Hospital: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: lead

MeSH Terms

Conditions

Cholelithiasis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Benjamin Petersen, M.D

CONTACT

+45 7918 5714; benjamin.drejer.petersen@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD Fellow

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share