GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GLP-1 receptor agonist therapy.
- Who it may be relevant to
- Registry conditions: Morbid Obesity, Anorectal Diseases, Drug-Related Side Effects and Adverse Reactions, Constipation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Proctologic Effects of GLP-1 Receptor Agonist Therapy in Morbidly Obese Patients: A Prospective Cohort Study With Baseline and 3-Month Proctologic Assessment
Overview
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.
Detailed description
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.
Interventions
- Drug 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.
Primary outcome measures
- Incidence of newly developed proctologic disease [Time frame: 3 months]
Secondary outcome measures (5)
- Change in anorectal symptom severity [Time frame: Baseline to 3 months]
- Change in bowel movement frequency [Time frame: Baseline to 3 months]
- Number of participants with worsening of pre-existing anorectal disease [Time frame: 3 months]
- Correlation between percent body weight loss and anorectal symptom score [Time frame: 3 months]
- Change in Bristol Stool Form Scale score [Time frame: Baseline to 3 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Gazi University Faculty of Medicine — Ankara
Publications
- 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
Identifiers
NCT: NCT07668765 · GU-GLP1-PROCT-2026