Gallstone DiseaseNCT07702630
ABCG8, UGT1A1 and Gallstone Disease After Bariatric Surgery
An observational study of Gallstone Disease and Bariatric Surgery, run by Esbjerg Hospital - University Hospital of Southern Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gallstone Disease, Bariatric Surgery, Metabolic Surgery
- What is being tested?
- blood sampling
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Bariatric surgery
Who cannot join
- Gallstone disease or cholecystectomy prior to bariatric surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ABCG8, UGT1A1 and Gallstone Disease After Bariatric Surgery: A Genetic Study
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.
Read more
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.
- Being tested
- blood sampling
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingDiagnostic test
Targeted genetic analysis of the ABCG8 D19H variant and the UGT1A1 rs6742078 variant using a blood sample.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery and subsequently cholecystectomy for gallstone disease | The case group. 135 patients. Receives: Diagnostic Test: blood sampling | |
| Bariatric surgery and no gallstone disease | Control group. A minimum of 5 years of follow up after bariatric surgery. Receives: Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallstone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, University of Southern Denmark
- Responsible party
- Principal investigator, Benjamin Drejer Petersen, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702630
- Sponsor's protocol ID
- EsbjergH (ABCG8)
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABCG8, UGT1A1 and Gallstone Disease After Bariatric Surgery: A Genetic Study
- ClinicalTrials.gov ID
- NCT07702630
- Acronym / sponsor ID
- EsbjergH (ABCG8)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, University of Southern Denmark
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery and subsequently cholecystectomy for gallstone disease | – | Diagnostic Test: blood samplingThe case group. 135 patients. |
| Bariatric surgery and no gallstone disease | – | Diagnostic Test: blood samplingControl group. A minimum of 5 years of follow up after bariatric surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Bariatric surgery
Key exclusion criteria (1 listed)
- Gallstone disease or cholecystectomy prior to bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingTargeted genetic analysis of the ABCG8 D19H variant and the UGT1A1 rs6742078 variant using a blood sample. | Diagnostic test | Bariatric surgery and no gallstone disease, Bariatric surgery and subsequently cholecystectomy for gallstone disease |
Primary outcome
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.
1 secondary outcome
Association Between UGT1A1 rs6742078 Carrier Status and Gallstone-Related Cholecystectomy After Bariatric Surgery
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstone Disease and Bariatric Surgery, run by Esbjerg Hospital - University Hospital of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Petersen, M.D (+45 7918 5714, benjamin.drejer.petersen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABCG8 carrier status (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.