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

NCT07668765 | Not Yet Recruiting

• 1 other identifier: GU-GLP1-PROCT-2026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Morbid Obesity; Anorectal Diseases; Drug-Related Side Effects and Adverse Reactions; Constipation; Diarrhea

Keywords

GLP-1 receptor agonist; obesity; anorectal symptoms; hemorrhoids; anal fissure; constipation; semaglutide; tirzepatide; proctologic examination; bowel habits; anorectal disease; proctology

Outcome Measures

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.

  3 months

Secondary Outcomes (5)

• Change in anorectal symptom severity

  Baseline to 3 months

• Change in bowel movement frequency

  Baseline to 3 months

• Number of participants with worsening of pre-existing anorectal disease

  3 months

• Correlation between percent body weight loss and anorectal symptom score

  3 months

• Change in Bristol Stool Form Scale score

  Baseline to 3 months

Study Arms (1)

Morbid obese patients initiating GLP-1 receptor agonist therapy

Drug: GLP-1 receptor agonist therapy

Interventions

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.

Morbid obese patients initiating GLP-1 receptor agonist therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• Filippatos TD, Panagiotopoulou TV, Elisaf MS. Adverse Effects of GLP-1 Receptor Agonists. Rev Diabet Stud. 2014 Fall-Winter;11(3-4):202-30. doi: 10.1900/RDS.2014.11.202. Epub 2015 Feb 10.

  PMID: 26177483 BACKGROUND

• Shankar 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 RESULT

• Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. 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. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831.

  PMID: 33625476 RESULT

MeSH Terms

Conditions

Obesity, Morbid; Rectal Diseases; Drug-Related Side Effects and Adverse Reactions; Constipation; Diarrhea; Obesity; Hemorrhoids; Fissure in Ano

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Chemically-Induced Disorders; Signs and Symptoms, Digestive; Vascular Diseases; Cardiovascular Diseases; Anus Diseases

Central Study Contacts

Mesut Yavaş, MD, Assistant of Professor

CONTACT

+903122025719; mesutyavas@gazi.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 25, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)