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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGazi University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inflammatory bowel disease

Perianal Crohn's disease

History of anorectal malignancy

Previous pelvic radiotherapy

Trial population

Morbidly obese adult patients who are newly prescribed GLP-1 receptor agonist therapy in routine clinical practice and are referred for participation in the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Morbid obese patients initiating GLP-1 receptor agonist therapy1 intervention

Trial outcomes

Primary outcomes

1

Incidence of newly developed proctologic disease

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.

Time frame
3 months

Secondary outcomes

1

Change in anorectal symptom severity

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

Time frame
Baseline to 3 months
2

Change in bowel movement frequency

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

Time frame
Baseline to 3 months
3

Number of participants with worsening of pre-existing anorectal disease

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.

Time frame
3 months
4

Correlation between percent body weight loss and anorectal symptom score

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.

Time frame
3 months

Other outcomes

Sponsors and contacts

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