24-hour Clear Liquid Diet vs. Standard Fasting for Upper Gastrointestinal Endoscopy in Patients Taking Agonists of the GLP-1 Receptor
Retained Gastric Content · Delayed Gastric Emptying · Obesity · Type 2 Diabetes Mellitus (DM)
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 250 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
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
Other: 24-Hour Clear Liquid Diet
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
Other: Standard Fasting
24-Hour Clear Liquid Diet OTHER
24-hour clear liquid diet prior to upper gastrointestinal endoscopy with a 2-hour complete fast, including for liquids
Standard Fasting OTHER
Standard fasting prior to upper gastrointestinal endoscopy, of 6-hours for solid foods and 2 hours for liquids
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Incidence of Retained Gastric Content
Plazo: 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.
Medidas secundarias
Procedure interruption rate due to retained gastric content and risk of aspiration
Plazo: Day 0
No informado en este registro.
Peri-procedural adverse events (aspiration, SpO₂ <90%, emergent advanced airway)
Plazo: Day 0
No informado en este registro.
Inadequate visualization rate (GRACE stomach 0-1 vs 2-3)
Plazo: 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.
Optimal visualization rate (GRACE stomach 3 vs 0-2)
Plazo: 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.
Gastric lesion detection rate
Plazo: 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.
Peri-procedural hypoglycemia (capillary glucose <70 mg/dL), before and after the procedure
Plazo: Day 0
No informado en este registro.
Otras medidas
Total GRACE score
Plazo: 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.
GRACE esophagus score
Plazo: Day 0
Gastroscopy RAte of Cleanliness Evaluation (GRACE) Esophagus Score; Range 0 to 3; higher scores indicate better mucosal cleanliness.
GRACE stomach score
Plazo: Day 0
Gastroscopy RAte of Cleanliness Evaluation (GRACE) Stomach Score; Range 0 to 3; higher scores indicate better mucosal cleanliness.
GRACE duodenum score
Plazo: Day 0
Gastroscopy RAte of Cleanliness Evaluation (GRACE) Duodenum Score; Range 0 to 3; higher scores indicate better mucosal cleanliness
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Portuguese Oncology Institute of CoimbraCoimbra, PortugalEstado desconocido
Equipo y fechas
- Patrocinador principal
- Portuguese Oncology Institute, Coimbra
- Inicio del estudio
- 2027-01 Estimado
- Finalización primaria
- 2027-12 Estimado
- Finalización del estudio
- 2027-12 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026