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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Rita Regatia, Doctor
- Numero di telefono: +351917835333
- Email: ritaregatia@gmail.com
Luoghi di studio
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Coimbra, Portogallo, 3030-508
- Portuguese Oncology Institute of Coimbra
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Contatto:
- Rita Regatia, Doctor
- Numero di telefono: +351917835333
- Email: ritaregatia@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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 |
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Comparatore attivo: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of Retained Gastric Content
Lasso di tempo: During the index upper gastrointestinal endoscopy (Day 0)
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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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Procedure interruption rate due to retained gastric content and risk of aspiration
Lasso di tempo: Day 0
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Day 0
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Peri-procedural adverse events (aspiration, SpO₂ <90%, emergent advanced airway)
Lasso di tempo: Day 0
|
Day 0
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Inadequate visualization rate (GRACE stomach 0-1 vs 2-3)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Day 0
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Day 0
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total GRACE score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema endocrino
- Disturbi della nutrizione
- Malattie metaboliche
- Ipernutrizione
- Peso corporeo
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Malattie dello stomaco
- Disturbi del metabolismo del glucosio
- Diabete mellito
- Sovrappeso
- Paralisi
- Condizioni patologiche, segni e sintomi
- Comportamento
- Malattie nutrizionali e metaboliche
- Segni e sintomi
- Comportamento alimentare
- Obesità
- Diabete mellito, tipo 2
- Gastroparesi
- Digiuno
Altri numeri di identificazione dello studio
- CLEAR-GLP1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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).
Periodo di condivisione IPD
Beginning 9 months and ending 36 months after publication of the primary results.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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