GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат GLP-1 receptor agonist therapy
  Participants will receive GLP-1 receptor agonist treatment as part of routine clinical care. The study does not assign treatment but prospectively evaluates proctologic outcomes following treatment initiation.

Первичные конечные точки

• Incidence of newly developed proctologic disease [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Change in anorectal symptom severity [Срок оценки: Baseline to 3 months]
• Change in bowel movement frequency [Срок оценки: Baseline to 3 months]
• Number of participants with worsening of pre-existing anorectal disease [Срок оценки: 3 months]
• Correlation between percent body weight loss and anorectal symptom score [Срок оценки: 3 months]
• Change in Bristol Stool Form Scale score [Срок оценки: Baseline to 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Gazi University Faculty of Medicine — Ankara

Публикации

• Filippatos TD, Panagiotopoulou TV, Elisaf MS. Adverse Effects of GLP-1 Receptor Agonists. Rev Diabet Stud. 2014 Fall-Winter;11(3-4):202-30. doi: 10.1900/RDS.2014.11.202. Epub 2015 Feb 10. PMID 26177483
• Shankar A, Sharma A, Vinas A, Chilton RJ. GLP-1 receptor agonists and delayed gastric emptying: implications for invasive cardiac interventions and surgery. Cardiovasc Endocrinol Metab. 2024 Dec 4;14(1):e00321. doi: 10.1097/XCE.0000000000000321. eCollection 2025 Mar. PMID 39649679
• Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama PMID 33625476

Идентификаторы

NCT: NCT07668765 · GU-GLP1-PROCT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗