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NCT Number: NCT07668765

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLP-1 receptor agonist therapy

Drug

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 outcomes

  1. Incidence of newly developed proctologic disease

    Time frame: 3 months

    Patients developing newly diagnosed anorectal pathology after initiation of GLP-1 receptor agonist therapy, including hemorrhoidal disease, anal fissure, pruritus ani, perianal irritation, or other proctologic conditions identified during follow-up examination.

Secondary outcomes

  1. Change in anorectal symptom severity

    Time frame: Baseline to 3 months

    Comparison of anorectal symptom severity between baseline and 3-month follow-up assessment.

  2. Change in bowel movement frequency

    Time frame: Baseline to 3 months

    Change in the number of bowel movements per week between baseline and 3-month follow-up after initiation of GLP-1 receptor agonist therapy.

  3. Number of participants with worsening of pre-existing anorectal disease

    Time frame: 3 months

    Number of participants demonstrating worsening of previously diagnosed anorectal disease based on changes in symptoms and findings on proctologic examination, including perianal inspection, digital rectal examination, and anoscopy.

  4. Correlation between percent body weight loss and anorectal symptom score

    Time frame: 3 months

    Correlation between percentage body weight loss and change in anorectal symptom score from baseline to 3-month follow-up after initiation of GLP-1 receptor agonist therapy.

  5. Change in Bristol Stool Form Scale score

    Time frame: Baseline to 3 months

    Change in Bristol Stool Form Scale score (Bristol Stool Form Scale, range 1-7; lower scores indicate harder stools and higher scores indicate looser stools) between baseline and 3-month follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Mesut Yavaş, MD, Assistant of Professor

CONTACT

[email protected]

+903122025719

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study 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

Acronym: GLP-PROCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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