- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07702630
ABCG8, UGT1A1 and Gallstone Disease After Bariatric Surgery
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.
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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Benjamin Petersen, M.D
- 전화번호: +45 7918 5714
- 이메일: benjamin.drejer.petersen@rsyd.dk
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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.
설명
Inclusion Criteria:
- Bariatric surgery
Exclusion Criteria:
- Gallstone disease or cholecystectomy prior to bariatric surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Bariatric surgery and subsequently cholecystectomy for gallstone disease
The case group. 135 patients.
|
Targeted genetic analysis of the ABCG8 D19H variant and the UGT1A1 rs6742078 variant using a blood sample.
|
|
Bariatric surgery and no gallstone disease
Control group.
A minimum of 5 years of follow up after bariatric surgery.
|
Targeted genetic analysis of the ABCG8 D19H variant and the UGT1A1 rs6742078 variant using a blood sample.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ABCG8 carrier status
기간: 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.
|
3 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Association Between UGT1A1 rs6742078 Carrier Status and Gallstone-Related Cholecystectomy After Bariatric Surgery
기간: 3 years
|
Association between UGT1A1 rs6742078 carrier status and gallstone-related cholecystectomy after bariatric surgery, estimated by comparing genotype frequencies between cases and controls.
|
3 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- EsbjergH (ABCG8)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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