Morbid ObesityGLP-PROCTNCT07668765
GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity
An observational study of Morbid Obesity and Anorectal Diseases, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity, Anorectal Diseases, Drug-Related Side Effects and Adverse Reactions
- What is being tested?
- GLP-1 receptor agonist therapy
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2026to May 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Inflammatory bowel disease
- Perianal Crohn's disease
- History of anorectal malignancy
- Previous pelvic radiotherapy
- Anorectal surgery within the previous 3 months
- Pregnancy
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gazi University Faculty of Medicine
Ankara
mESUT Yavaş, MD, +903122025719, mesutyavas@gazi.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Morbid Obesity, Anorectal Diseases, Drug-Related Side Effects and Adverse Reactions, Constipation, Diarrhea
- Being tested
- GLP-1 receptor agonist therapy
- Keywords
- GLP-1 receptor agonist, obesity, anorectal symptoms, hemorrhoids, anal fissure, constipation, semaglutide, tirzepatide, proctologic examination, bowel habits, anorectal disease, proctology
- Medical subject headings
- Obesity, Morbid, Rectal Diseases, Drug-Related Side Effects and Adverse Reactions, Constipation, Diarrhea, Obesity, Hemorrhoids, Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 receptor agonist therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Morbid obese patients initiating GLP-1 receptor agonist therapy | Not described Receives: Drug: GLP-1 receptor agonist therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Change in anorectal symptom severity
Comparison of anorectal symptom severity between baseline and 3-month follow-up assessment.
Measured: Baseline to 3 months
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.
Measured: Baseline to 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Change in Bristol Stool Form Scale score
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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut YAVAS, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668765
- Sponsor's protocol ID
- GU-GLP1-PROCT-2026
- Acronym
- GLP-PROCT
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26177483Shankar 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.
PubMed 39649679Wadden 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.
PubMed 33625476
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Proctologic Effects of GLP-1 Receptor Agonist Therapy in Morbidly Obese Patients: A Prospective Cohort Study With Baseline and 3-Month Proctologic Assessment
- ClinicalTrials.gov ID
- NCT07668765
- Acronym / sponsor ID
- GLP-PROCT / GU-GLP1-PROCT-2026
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morbid obese patients initiating GLP-1 receptor agonist therapy | – | Drug: GLP-1 receptor agonist therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Inflammatory bowel disease
- Perianal Crohn's disease
- History of anorectal malignancy
- Previous pelvic radiotherapy
- Anorectal surgery within the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 receptor agonist therapyParticipants 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. | Drug | Morbid obese patients initiating GLP-1 receptor agonist therapy |
Primary outcome
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.
5 secondary outcomes
Change in anorectal symptom severity
Time frame: Baseline to 3 months
Change in bowel movement frequency
Time frame: Baseline to 3 months
Number of participants with worsening of pre-existing anorectal disease
Time frame: 3 months
Correlation between percent body weight loss and anorectal symptom score
Time frame: 3 months
Change in Bristol Stool Form Scale score
Time frame: Baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 26177483Filippatos 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.
- Results publication: PubMed 39649679Shankar 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.
- Results publication: PubMed 33625476Wadden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Anorectal Diseases, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mesut Yavaş, MD, Assistant of Professor (+903122025719, mesutyavas@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of newly developed proctologic disease (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07668765, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.