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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Benjamin Petersen, M.D
- 電話番号：+45 7918 5714
- メール：benjamin.drejer.petersen@rsyd.dk
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
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.
説明
Inclusion Criteria:
- Bariatric surgery
Exclusion Criteria:
- Gallstone disease or cholecystectomy prior to bariatric surgery
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ABCG8 carrier status
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Association Between UGT1A1 rs6742078 Carrier Status and Gallstone-Related Cholecystectomy After Bariatric Surgery
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- EsbjergH (ABCG8)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。