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临床试验/NCT07736963
NCT07736963招募中不适用

Discontinuation Recommendations for GLP-1 Receptor Agonists Prior to Colonoscopy: A Randomized Controlled Trial in Taiwan.

Fu Jen Catholic University Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
1
主要终点
.Incomplete bowel preparation rate(IBP) through BBPS(Boston Bowel Preparation Scale)

研究概览

简要总结

This study aims to evaluate the impact of different discontinuation intervals of GLP-1 receptor agonists prior to colonoscopy on bowel preparation quality and the need for repeat colonoscopy, in order to establish appropriate discontinuation recommendations.

详细描述

Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have become increasingly prevalent in modern clinical practice, extending their therapeutic roles beyond glycemic control in type 2 diabetes mellitus (T2DM) to encompass weight management, cardiovascular protection, and emerging indications in hepatic diseases. The growing adoption of GLP-1 RAs, including newer agents such as tirzepatide, has highlighted their beneficial effects on metabolic health. However, their pharmacological action of delaying gastric emptying and suppressing gastrointestinal motility has raised concerns regarding their potential impact on bowel preparation quality prior to colonoscopy.

Colonoscopy remains a cornerstone modality for colorectal cancer screening and prevention, where high-quality bowel preparation is essential for adequate mucosal visualization and lesion detection. Inadequate bowel preparation not only compromises diagnostic accuracy but also increases the risk of missed lesions, procedural complications, and necessitates repeat examinations, leading to greater healthcare costs and patient burden. Current guidelines advocate split-dose polyethylene glycol (PEG)-based regimens as the standard for bowel cleansing; however, patient-related factors, including the use of medications that inhibit gastrointestinal motility, are recognized contributors to bowel preparation failure.

GLP-1 RAs are classified as enterogastrones, exerting their effects via the ileal brake mechanism, which slows upper gastrointestinal transit in response to nutrient exposure. While this effect is therapeutically advantageous for glycemic control and weight reduction, it may inadvertently impair bowel cleansing efficacy. Preliminary evidence suggests that GLP-1 RA users are at higher risk of inadequate bowel preparation and repeat colonoscopy. Nonetheless, empirical data regarding optimal peri-procedural management, specifically the appropriate discontinuation interval of GLP-1 RAs prior to colonoscopy, remain scarce.

Given the pharmacokinetic diversity of GLP-1 RAs and their prolonged half-lives, it is unclear how long prior to colonoscopy these agents should be withheld to mitigate their gastrointestinal motility-suppressing effects and reduce the likelihood of suboptimal bowel cleansing. The absence of evidence-based discontinuation guidelines for GLP-1 RAs in this setting represents an unmet clinical need.

This study aims to evaluate the relationship between GLP-1 RA discontinuation intervals and bowel preparation adequacy, Using BBPS(Boston Bowel Preparation Scale) as a surrogate marker for inadequate bowel cleansing. By determining the optimal discontinuation timeframe for GLP-1 RAs, we seek to provide clinically actionable recommendations to optimize colonoscopy outcomes in this growing patient population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria for non GLP-1 user:
  • Individuals who are scheduled to undergo total colonoscopy for any reasons
  • Age between 18 to 70 years.
  • ECOG Performance status is 0 or
  • Written consent to participate in the study has been obtained.
  • Outpatient department patient
  • Stop at least 3 days if current using medications that promote or inhibit gastrointestinal motility.

排除标准

  • • Presence of severe comorbid conditions that preclude the safe performance of colonoscopy (e.g., unstable angina, recent myocardial infarction, decompensated heart failure, chronic respiratory disease, or bleeding diathesis).
  • History of prior gastric, small bowel, or colorectal segmental resection (patients with isolated appendectomy are eligible).
  • Family history of hereditary colorectal cancer syndromes.
  • Current or prior diagnosis of inflammatory bowel disease.
  • Known colorectal polyposis syndromes.
  • Any other condition deemed inappropriate for study participation at the discretion of the treating physician.
  • Body mass index (BMI) > 40 kg/m².
  • Diagnosis of liver cirrhosis.
  • Diagnosis of Parkinson's disease.
  • Diagnosis of dementia.
  • Use of tricyclic antidepressants or opioid medications for more than 3 months.

研究组 & 干预措施

GLP-1 stop for 1 week

Active Comparator

GLP-1 stop for 1 week

干预措施: GLP-1 stop for 1 week (Behavioral)

GLP-1 not stop for 1 week

Placebo Comparator

GLP-1 not stop for 1 week

干预措施: GLP-1 not stop for 1 week (Behavioral)

结局指标

主要结局

.Incomplete bowel preparation rate(IBP) through BBPS(Boston Bowel Preparation Scale)

时间窗: "From enrollment to the end of Procedure and follow up for 30 days"

Effect: Primary outcome: 1.Incomplete bowel preparation rate(IBP) through BBPS(Boston Bowel Preparation Scale) (Total BBPS score \< = 5 or score \<= 1 in any segment) Secondary outcomes: 1. Adenoma detection rate (ADR) 2. Detection rate number of advanced adenomas and colorectal serrated lesions 3. Time for scope insertion to cecum and withdrawal from the cecum to rectum. 4. Incidence of adverse events during colonoscopy 5. Weight gain or HSS was recorded after stopping GLP-1 and before colonoscopy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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