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临床试验/NCT07668765
NCT07668765尚未招募不适用

Early Proctologic Effects of GLP-1 Receptor Agonist Therapy in Morbidly Obese Patients: A Prospective Cohort Study With Baseline and 3-Month Proctologic Assessment

Gazi University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1

研究概览

简要总结

Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants will undergo baseline and 3-month anorectal symptom assessment and proctologic examination to evaluate newly developed proctologic diseases and changes in pre-existing symptoms.

详细描述

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly used in the treatment of obesity and type 2 diabetes mellitus. Although gastrointestinal adverse effects such as constipation, diarrhea, nausea, delayed gastric emptying, and altered bowel habits are well recognized, their potential impact on anorectal symptoms and proctologic diseases remains poorly investigated.

Changes in bowel habits and stool consistency associated with GLP-1 RA therapy may contribute to the development or progression of anorectal disorders including hemorrhoidal disease, anal fissures, perianal irritation, pruritus ani, and fecal incontinence. However, prospective clinical data evaluating these associations are lacking.

This prospective observational cohort study aims to evaluate the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants who are newly prescribed GLP-1 RA treatment will undergo baseline assessment before treatment initiation and follow-up evaluation at 3 months.

Baseline evaluation will include demographic characteristics, comorbidities, bowel habit assessment, anorectal symptom assessment, and standardized proctologic examination including perianal inspection, digital rectal examination, and anoscopy. Follow-up evaluation at 3 months will reassess symptoms and repeat proctologic examination.

The primary objective is to determine the incidence of newly developed proctologic diseases during the first 3 months after initiation of GLP-1 receptor agonist therapy. Secondary objectives include evaluating changes in anorectal symptom severity, bowel habits, progression of pre-existing anorectal disease, and the relationship between weight loss magnitude and anorectal symptoms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥18 years
  • Morbid obesity (BMI ≥40 kg/m² or BMI ≥35 kg/m² with obesity-related comorbidities)
  • Newly prescribed GLP-1 receptor agonist therapy
  • Ability and willingness to provide written informed consent
  • Ability to attend 3-month follow-up visit

排除标准

  • Inflammatory bowel disease
  • Perianal Crohn's disease
  • History of anorectal malignancy
  • Previous pelvic radiotherapy
  • Anorectal surgery within the previous 3 months
  • Pregnancy
  • Neurogenic bowel dysfunction
  • Inability to comply with follow-up visits
  • Discontinuation of GLP-1 receptor agonist therapy before follow-up assessment
  • Active anorectal infection or abscess

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mesut YAVAS

Principal Investigator

Gazi University

研究点 (1)

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