An observational study in Morbid Obesity, Anorectal Diseases and Drug-Related Side Effects and Adverse Reactions, sponsored by Gazi University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Gazi University · Observational
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.
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.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 311 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Gazi University is the lead sponsor of 551 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
This study also gives Semaglutide, Tirzepatide. No intervention listed here names it: that was found by reading the record.
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
Change in anorectal symptom severity
Comparison of anorectal symptom severity between baseline and 3-month follow-up assessment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 3 months
Plan to share: No
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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