24-hour Clear Liquid Diet vs. Standard Fasting for Upper Gastrointestinal Endoscopy in Patients Taking Agonists of the GLP-1 Receptor (CLEAR-GLP1)
24-hour Clear Liquid Diet vs. Standard Fasting for Upper Gastrointestinal Endoscopy in Patients Taking Agonists of the GLP-1 Receptor (CLEAR-GLP1 Trial): a Randomized, Parallel-group, Multicentre, International Clinical Trial
GLP-1 receptor agonists delay gastric emptying and are associated with a higher rate of retained gastric content (RGC) during upper gastrointestinal endoscopy, even under standard fasting. No randomized trial has compared fasting strategies in this population. CLEAR-GLP1 is a multicentre, international, investigator-blinded randomized trial comparing a 24-hour clear liquid diet (followed by a 2-hour fast) with standard fasting (6 hours for solids, 2 hours for clear liquids) in adults on GLP-1 RA therapy undergoing elective upper endoscopy. GLP-1 RA therapy is not interrupted in either arm. The primary outcome is the rate of clinically significant RGC, defined as a GRACE stomach score of 0.
調査の概要
状態
詳細な説明
The primary objective of the study it to determine whether a 24-hour clear liquid diet protocol reduces the incidence of retained gastric content compared with a standard fasting protocol, graded endoscopically using a validated visibility scale (stomach GRACE score=0 vs. stomach GRACE scores=1, 2 or 3), in patients on GLP-1 receptor agonist therapy undergoing elective UGI endoscopy.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Rita Regatia, Doctor
- 電話番号：+351917835333
- メール：ritaregatia@gmail.com
研究場所
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Coimbra、ポルトガル、3030-508
- Portuguese Oncology Institute of Coimbra
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コンタクト：
- Rita Regatia, Doctor
- 電話番号：+351917835333
- メール：ritaregatia@gmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age ≥ 18 years;
- Current treatment with a GLP-1 receptor agonist for at least 4 weeks, regardless of indication;
- Referral for elective upper gastrointestinal endoscopy (isolated or combined with colonoscopy);
- Informed consent for both the upper gastrointestinal endoscopy procedure and study participation.
Exclusion Criteria:
- Urgent/emergency endoscopy;
- Previously diagnosed gastroparesis;
- Prior major gastric/esophageal surgery (e.g., gastrectomy, gastric bypass);
- Known or suspected upper gastrointestinal obstruction;
- Pregnancy;
- Refusal or inability to comply with the assigned fasting protocol.
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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：24-Hour Clear Liquid Diet
24-hour clear liquid diet: exclusively clear liquids for the 24 hours preceding the upper gastrointestinal endoscopy, with a 2-hour complete fast, including for liquids |
24-hour clear liquid diet prior to upper gastrointestinal endoscopy with a 2-hour complete fast, including for liquids |
|
アクティブコンパレータ：Standard Fasting
Standard pre-procedural fasting according to current recommendations: the patient keeps a standard fasting prior to the upper gastrointestinal endoscopy, with a 6-hour fast for solid food and 2-hour fast for liquids |
Standard fasting prior to upper gastrointestinal endoscopy, of 6-hours for solid foods and 2 hours for liquids |
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 |
|---|---|---|
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Incidence of Retained Gastric Content
時間枠：During the index upper gastrointestinal endoscopy (Day 0)
|
Proportion of patients with clinically significant retained gastric content, defined as a GRACE (Gastroscopy RAte of Cleanliness Evaluation) stomach score of 0 (solid food precluding visualization of the underlying mucosa), compared with GRACE stomach scores of 1, 2 or 3. The GRACE stomach score ranges from 0 to 3; higher scores indicate better mucosal cleanliness. |
During the index upper gastrointestinal endoscopy (Day 0)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedure interruption rate due to retained gastric content and risk of aspiration
時間枠：Day 0
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Day 0
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Peri-procedural adverse events (aspiration, SpO₂ <90%, emergent advanced airway)
時間枠：Day 0
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Day 0
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Inadequate visualization rate (GRACE stomach 0-1 vs 2-3)
時間枠：Day 0
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Percentage of participants with a Gastroscopy RAte of Cleanliness Evaluation (GRACE) stomach score of 0 or 1, compared with scores of 2 or 3. The GRACE stomach score ranges from 0 to 3; higher scores indicate better mucosal cleanliness. |
Day 0
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Optimal visualization rate (GRACE stomach 3 vs 0-2)
時間枠：Day 0
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Percentage of participants with a Gastroscopy RAte of Cleanliness Evaluation (GRACE) stomach score of 3, compared with scores of 0, 1 or 2. The GRACE stomach score ranges from 0 to 3; higher scores indicate better mucosal cleanliness. |
Day 0
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Gastric lesion detection rate
時間枠：Up to 4 weeks
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Gastric lesion detection rate defined as the detection of any subepithelial lesion, extensive intestinal metaplasia, dysplasia, carcinoma, neuroendocrine tumour, or lymphoma. |
Up to 4 weeks
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Peri-procedural hypoglycemia (capillary glucose <70 mg/dL), before and after the procedure
時間枠：Day 0
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Day 0
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total GRACE score
時間枠：Day 0
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Gastroscopy RAte of Cleanliness Evaluation (GRACE) Total Score Sum of the esophagus, stomach and duodenum GRACE scores; Range 0 to 9; higher scores indicate better mucosal cleanliness. |
Day 0
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GRACE esophagus score
時間枠：Day 0
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Gastroscopy RAte of Cleanliness Evaluation (GRACE) Esophagus Score; Range 0 to 3; higher scores indicate better mucosal cleanliness. |
Day 0
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GRACE stomach score
時間枠：Day 0
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Gastroscopy RAte of Cleanliness Evaluation (GRACE) Stomach Score; Range 0 to 3; higher scores indicate better mucosal cleanliness. |
Day 0
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GRACE duodenum score
時間枠：Day 0
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Gastroscopy RAte of Cleanliness Evaluation (GRACE) Duodenum Score; Range 0 to 3; higher scores indicate better mucosal cleanliness |
Day 0
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Areia M, Esposito G, Leclercq P, Romanczyk M, Zessner-Spitzenberg J, Delgado Guillena PG, Monged A, Honrubia Lopez R, Uchima H, Ruiz Ballesteros EJ, Panarese A, Reis de Oliveira LA, Afify S, Bisschops R, Ferlitsch M; External Voting Panel. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative - Update 2025. Endoscopy. 2025 Nov;57(11):1268-1297. doi: 10.1055/a-2674-4912. Epub 2025 Sep 11.
- Esposito G, Dilaghi E, Costa-Santos C, Ligato I, Annibale B, Dinis-Ribeiro M, Areia M; GRACE Investigators. The Gastroscopy RAte of Cleanliness Evaluation (GRACE) Scale: an international reliability and validation study. Endoscopy. 2025 Apr;57(4):312-320. doi: 10.1055/a-2422-0856. Epub 2024 Sep 25.
- Ahmad AI, Garg S, Jacobs J, Ansari Z, Al-Din TJ, Almomani A, Valencia S, Vargo J, Chatterjee A, Siddiki H, Hong L, Nicolas MA, Miller A, Shah T. Holding vs Continuing GLP-1/GIP Agonists Before Upper Endoscopy: The OCULUS Randomized Clinical Trial. JAMA Intern Med. 2026 May 1;186(5):578-584. doi: 10.1001/jamainternmed.2026.0027.
- Nasser J, Hosseini A, Barlow G, Gianchandani R, Rezaie A, Pimentel M, Mathur R. Food Retention at Endoscopy Among Adults Using Glucagon-Like Peptide-1 Receptor Agonists. JAMA Netw Open. 2024 Oct 1;7(10):e2436783. doi: 10.1001/jamanetworkopen.2024.36783.
- Ukwade D, Hernandez LJ, Modi Z, Raza HS, Siegel M, Nwachukwu D, Sarraf P, Memon A, Booth M, Cooper K, Boulay BR, Mutlu EA. GLP-1 receptor agonist increase retained gastric contents on EGD and same-day colonoscopy reduces this risk. Front Med (Lausanne). 2025 Sep 10;12:1638981. doi: 10.3389/fmed.2025.1638981. eCollection 2025.
- Gu GH, Pauplis C, Seacor T, Devuni D, Krishnarao A. Association of semaglutide with retained gastric contents on endoscopy: Retrospective analysis. Endosc Int Open. 2025 Apr 4;13:a25501468. doi: 10.1055/a-2550-1468. eCollection 2025.
- Triantafyllou K, Tziatzios G, Tham TC, Beilenhoff U, Lorenzo-Zuniga V, Pouw RE, Roelandt P, van Malenstein H, Vilmann P, Voiosu T, Abu-Freha N, Becq A, Coron E, Garborg K, Hollenbach M, Kovacevic B, Manno M, Parrella A, Pontone S, Romanczyk M, Sa PA, Soria San Teodoro MT, Turnbull D, Sidhu R. Sedation for gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) Guideline. Endoscopy. 2026 Oct;58(10):1142-1179. doi: 10.1055/a-2898-6540. Epub 2026 Jul 21.
- Baig MU, Piazza A, Lahooti A, Johnson KE, Rangwani S, Gouda Z, Mahadev S, Newberry C, Hanscom M, Sampath K, Kumar S, Anca D, Schulman AR, Carr-Locke DL, Sharaiha RZ. Glucagon-like peptide-1 receptor agonist use and the risk of residual gastric contents and aspiration in patients undergoing GI endoscopy: a systematic review and a meta-analysis. Gastrointest Endosc. 2025 Apr;101(4):762-771.e13. doi: 10.1016/j.gie.2024.12.019. Epub 2024 Dec 16.
- Facciorusso A, Ramai D, Dhar J, Samanta J, Chandan S, Gkolfakis P, Crino SF, Maida M, Anderloni A, Boskoski I, Triantafyllou K, Dinis-Ribeiro M, Hassan C, Fuccio L, Arvanitakis M. Effects of Glucagon-Like Peptide-1 Receptor Agonists on Upper Gastrointestinal Endoscopy: A Meta-Analysis. Clin Gastroenterol Hepatol. 2025 Apr;23(5):715-725.e3. doi: 10.1016/j.cgh.2024.07.021. Epub 2024 Aug 12.
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CLEAR-GLP1
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
De-identified individual participant data underlying the results reported in the primary publication (baseline characteristics, fasting arm, GLP-1 RA type and dose, time since last dose, GRACE scores, adverse events and lesion detection) will be shared, in compliance with the General Data Protection Regulation (GDPR).
IPD 共有時間枠
Beginning 9 months and ending 36 months after publication of the primary results.
IPD 共有アクセス基準
Researchers who provide a methodologically sound proposal, approved by the principal investigator. Proposals should be directed by email. To gain access, data requestors will need to sign a data access agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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