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24-hour Clear Liquid Diet vs. Standard Fasting for Upper Gastrointestinal Endoscopy in Patients Taking Agonists of the GLP-1 Receptor (CLEAR-GLP1)

2026年11月5日更新者：Rita Regatia、Portuguese Oncology Institute, Coimbra

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

250

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Rita Regatia, Doctor
电话号码：+351917835333
邮箱：ritaregatia@gmail.com

学习地点

葡萄牙
- - Coimbra、葡萄牙、3030-508
    - Portuguese Oncology Institute of Coimbra
    - 接触：
      
      Rita Regatia, Doctor
      
      电话号码：+351917835333
      
      邮箱：ritaregatia@gmail.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：预防
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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	其他：24-Hour Clear Liquid Diet 24-hour clear liquid diet prior to upper gastrointestinal endoscopy with a 2-hour complete fast, including for liquids
有源比较器：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	其他：Standard Fasting Standard fasting prior to upper gastrointestinal endoscopy, of 6-hours for solid foods and 2 hours for liquids

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Incidence of Retained Gastric Content 大体时间：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)

次要结果测量

结果测量	措施说明	大体时间
Procedure interruption rate due to retained gastric content and risk of aspiration 大体时间：Day 0		Day 0
Peri-procedural adverse events (aspiration, SpO₂ <90%, emergent advanced airway) 大体时间：Day 0		Day 0
Inadequate visualization rate (GRACE stomach 0-1 vs 2-3) 大体时间：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) 大体时间：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 大体时间：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 大体时间：Day 0		Day 0

其他结果措施

结果测量	措施说明	大体时间
Total GRACE score 大体时间：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 大体时间：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 大体时间：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 大体时间：Day 0	Gastroscopy RAte of Cleanliness Evaluation (GRACE) Duodenum Score; Range 0 to 3; higher scores indicate better mucosal cleanliness	Day 0

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Portuguese Oncology Institute, Coimbra

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

24-hour Clear Liquid Diet vs. Standard Fasting for Upper Gastrointestinal Endoscopy in Patients Taking Agonists of the GLP-1 Receptor (CLEAR-GLP1)