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

June 23, 2026 updated by: Mesut YAVAS, Gazi University

Early Proctologic Effects of GLP-1 Receptor Agonist Therapy in Morbidly Obese Patients: A Prospective Cohort Study With Baseline and 3-Month Proctologic Assessment

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Morbid obese patients initiating GLP-1 receptor agonist therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anorectal symptom severity
Time Frame: Baseline to 3 months
Comparison of anorectal symptom severity between baseline and 3-month follow-up assessment.
Baseline to 3 months
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.
Baseline to 3 months
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.
3 months
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.
3 months
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.
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GU-GLP1-PROCT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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