Current partner codePEPTIDESDE
NCT07668765·Not applicable·OBSERVATIONAL

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

Status

Not yet recruiting

Phase

Not applicable

Enrollment

100

Locations

1

Results

Not posted

Publications

3

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jun 25, 2026

  2. Study start

    Aug 2026

  3. Primary completion

    Apr 2027

  4. Study completion

    May 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jun 25, 2026

Outcomes

What the study measures.

Primary outcomes

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

Change in anorectal symptom severity

Time frame · Baseline to 3 months

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

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.

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.

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.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.

Gazi University Faculty of Medicine

Ankara, Turkey (Türkiye)

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.