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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Rita Regatia, Doctor
- Telefonnummer: +351917835333
- E-mail: ritaregatia@gmail.com
Studiesteder
-
-
-
Coimbra, Portugal, 3030-508
- Portuguese Oncology Institute of Coimbra
-
Kontakt:
- Rita Regatia, Doctor
- Telefonnummer: +351917835333
- E-mail: ritaregatia@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
|
Aktiv komparator: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Retained Gastric Content
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procedure interruption rate due to retained gastric content and risk of aspiration
Tidsramme: Day 0
|
Day 0
|
|
|
Peri-procedural adverse events (aspiration, SpO₂ <90%, emergent advanced airway)
Tidsramme: Day 0
|
Day 0
|
|
|
Inadequate visualization rate (GRACE stomach 0-1 vs 2-3)
Tidsramme: Day 0
|
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
|
|
Optimal visualization rate (GRACE stomach 3 vs 0-2)
Tidsramme: Day 0
|
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
|
|
Gastric lesion detection rate
Tidsramme: Up to 4 weeks
|
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
|
|
Peri-procedural hypoglycemia (capillary glucose <70 mg/dL), before and after the procedure
Tidsramme: Day 0
|
Day 0
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total GRACE score
Tidsramme: Day 0
|
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
|
|
GRACE esophagus score
Tidsramme: Day 0
|
Gastroscopy RAte of Cleanliness Evaluation (GRACE) Esophagus Score; Range 0 to 3; higher scores indicate better mucosal cleanliness. |
Day 0
|
|
GRACE stomach score
Tidsramme: Day 0
|
Gastroscopy RAte of Cleanliness Evaluation (GRACE) Stomach Score; Range 0 to 3; higher scores indicate better mucosal cleanliness. |
Day 0
|
|
GRACE duodenum score
Tidsramme: Day 0
|
Gastroscopy RAte of Cleanliness Evaluation (GRACE) Duodenum Score; Range 0 to 3; higher scores indicate better mucosal cleanliness |
Day 0
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i det endokrine system
- Ernæringsforstyrrelser
- Metaboliske sygdomme
- Overernæring
- Kropsvægt
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Glukosemetabolismeforstyrrelser
- Diabetes mellitus
- Overvægtig
- Lammelse
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Fodringsadfærd
- Fedme
- Diabetes mellitus, type 2
- Gastroparese
- Faste
Andre undersøgelses-id-numre
- CLEAR-GLP1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
Beginning 9 months and ending 36 months after publication of the primary results.
IPD-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .