ABCG8, UGT1A1 and Gallstone Disease After Bariatric Surgery: A Genetic Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 主要终点
- ABCG8 carrier status
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bariatric surgery
排除标准
- •Gallstone disease or cholecystectomy prior to bariatric surgery
研究组 & 干预措施
Bariatric surgery and no gallstone disease
Control group. A minimum of 5 years of follow up after bariatric surgery.
干预措施: blood sampling (Diagnostic Test)
Bariatric surgery and subsequently cholecystectomy for gallstone disease
The case group. 135 patients.
干预措施: blood sampling (Diagnostic Test)
结局指标
主要结局
ABCG8 carrier status
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Benjamin Drejer Petersen
M.D., PhD Fellow
Esbjerg Hospital - University Hospital of Southern Denmark