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Trial · Observational

Not yet recruitingPhase not statedRegistry data

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

Short name GLP-PROCT

NCTNCT07668765 (opens ClinicalTrials.gov in a new tab)Other idGU-GLP1-PROCT-2026
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Semaglutide, does not test it. It appears in the conditions.
  • Names Tirzepatide, does not test it. It appears in the conditions.

Overview

Status
Not yet recruiting
Phase
Phase not stated
Enrollment
100 participants (estimated)
Sponsor
Gazi University · Other
Design
Not stated
Countries
1 country

Turkey (Türkiye)

Start
Aug 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
May 2027 (estimated)
First posted
25 Jun 2026
Last update posted
25 Jun 2026
Conditions
Morbid Obesity · Anorectal Diseases · Drug-Related Side Effects and Adverse Reactions · Constipation · Diarrhea

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph –

    GLP-PROCT

    NCT07668765

    est. Aug 2026 to est. May 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GLP-1 receptor agonist therapyDrug

Arms1

  • Other

    Morbid obese patients initiating GLP-1 receptor agonist therapy

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of newly developed proctologic disease

    Time frame · 3 months

    Registry description

    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(5)

  1. Change in anorectal symptom severity

    Time frame · Baseline to 3 months

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

6 results

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.

Wadden et al. 2021JAMAcited by 858

PMID 33625476PMC7905697DOI 10.1001/jama.2021.1831PUB-33625476

Rights unknown6 results
Source linkSee results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultShankar 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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