Changes in immune cells and small blood vessels in the stomach of people with obesity
Understanding Alterations in Mast Cell and Macrophage Infiltration, as Well as Micro Vessel Density, May Throw Light on the Early Events Leading to Gastric Carcinogenesis in Obesity
This project tests whether adults with obesity who are having sleeve gastrectomy have more mast cells, macrophages, and tiny blood vessels in their stomach lining compared with lean control patients undergoing endoscopic biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | General Committee of Teaching Hospitals and Institutes, Egypt Government |
| Locations | 1 site (Alexandria, Alexandria Governorate) |
| Trial ID | NCT07448896 on ClinicalTrials.gov |
What this trial studies
This is an observational, single-center study that compares gastric mucosal tissue from adults with BMI >35 kg/m² undergoing laparoscopic sleeve gastrectomy to lean control patients who have endoscopic biopsies. Tissue samples will be examined histologically and by immunohistochemistry to quantify mast cell and macrophage infiltration and microvessel density. Patients with secondary causes of obesity, prior gastric surgery, systemic inflammatory diseases, recent immunosuppressive or corticosteroid use, or malignant gastric conditions are excluded. The goal is to characterize early immunopathological and angiogenic changes in obese gastric mucosa that might relate to carcinogenic risk.
Who should consider this trial
Good fit: Adults with BMI >35 kg/m² scheduled for laparoscopic sleeve gastrectomy who have completed standard preoperative evaluation and are not on recent immunosuppressive or corticosteroid therapy.
Not a fit: People with secondary causes of obesity, prior gastric surgery, active systemic inflammatory or autoimmune disease, recent immunosuppressive/corticosteroid use, or existing malignant gastric conditions are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could reveal early inflammatory and vascular changes in obese stomach tissue that help identify people at higher risk and inform future prevention or monitoring strategies.
How similar studies have performed: Animal models and some human studies link obesity-related inflammation to cancer, but direct analyses of mast cells, macrophages, and microvessel density in pre-cancerous human gastric mucosa are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients undergoing bariatric surgery (laparoscopic sleeve gastrectomy). * BMI \> 35 kg/m² * All participants underwent preoperative evaluation, including blood tests and assessment by a multidisciplinary team (nutritionist, psychiatrist, endocrinologist, radiologist, anesthesiologist, and surgeon). Exclusion Criteria: * Patients with secondary causes of obesity, such as Cushing's syndrome or polycystic ovary syndrome (PCOS). * Patients with malignant gastric conditions or previous gastric surgery. * Patients with systemic inflammatory diseases, autoimmune disorders, or chronic infections that may influence immune cell infiltration. * Patients with incomplete clinical data or poor-quality tissue samples. * Patients taking anti-inflammatory, immunosuppressive, or corticosteroid therapy within the last 3 months before sampling.
Where this trial is running
Alexandria, Alexandria Governorate
- The surgical department of Medical Research Institute Hospital, Alexandria University — Alexandria, Alexandria Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed H Ashour, PhD
- Email: dr.mhany@gmail.com
- Phone: 00201002600970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.