ObesityNCT07448896
Gastric Mucosal Mast Cells, Macrophages and Microvessels in Obesity
An observational study of Obesity, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial summary
This comparative cross-sectional study compared tryptase-positive mast cells, CD68-positive macrophages, and CD31-positive microvessels in the gastric mucosa of 31 patients with obesity undergoing sleeve gastrectomy and 33 participants without obesity undergoing diagnostic endoscopy. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Sleeve gastrectomy and Diagnostic upper gastrointestinal endoscopy with biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 25 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with obesity undergoing elective sleeve gastrectomy and participants without obesity (BMI below 30 kg/m²) undergoing diagnostic upper gastrointestinal endoscopy at the Medical Research Institute Hospital, Alexandria University, Egypt, between January and December 2025. Of 835 candidates screened (634 for sleeve gastrectomy, 201 for endoscopy), 771 were excluded or declined, and 64 were enrolled (31 and 33).
Who may be able to join
- Cases: patients aged 17 years or older with obesity scheduled for elective sleeve gastrectomy according to the 2022 ASMBS/IFSO indications for metabolic and bariatric surgery.
- Controls: participants aged 17 years or older with BMI below 30 kg/m² undergoing diagnostic upper gastrointestinal endoscopy for benign indications, such as mild dyspepsia, with no endoscopic evidence of active gastric mucosal disease.
- Negative rapid urease test for Helicobacter pylori on antral biopsy.
- Written informed consent.
Who cannot join
- Positive rapid urease test.
- Active erosive gastritis, peptic ulcer disease, or suspected or confirmed gastric malignancy at endoscopy.
- Current cigarette smoking, or smoking cessation within 6 months before enrollment.
- Prior gastric surgery.
- Secondary causes of obesity, such as Cushing's syndrome or hypothyroidism.
- Systemic autoimmune disease or inflammatory bowel disease.
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- Active malignancy, or a major systemic infection within 3 months before sampling.
- Long-term non-steroidal anti-inflammatory drug use, proton pump inhibitor use for more than 6 months, or immunosuppressive or corticosteroid therapy within 3 months before sampling.
- For controls: BMI of 30 kg/m² or higher.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, Alexandria Governorate, 21531
About this study
Official title: Gastric Mucosal Mast Cells, Macrophages and Microvessels in Patients With Obesity Undergoing Sleeve Gastrectomy: A Comparative Cross-Sectional Immunohistochemical Study
This comparative cross-sectional study compared tryptase-positive mast cells, CD68-positive macrophages, and CD31-positive microvessels in the gastric mucosa of 31 patients with obesity undergoing sleeve gastrectomy and 33 participants without obesity undergoing diagnostic endoscopy. Active Helicobacter pylori infection, recent smoking, and overt mucosal disease were excluded.
Read the detailed description
Participants were enrolled and gastric tissue was collected at the Medical Research Institute Hospital, Alexandria University, between January and December 2025. This record was first submitted on 20 February 2026, after enrollment had closed, and was updated in October 2026 so that its dates, enrollment, design and eligibility describe the completed study; the three marker outcomes were kept, and extracellular tryptase is listed as a qualitative observation. In both groups, tissue came from the greater curvature of the mid-body. A pathologist blinded to group counted each marker in five mucosal hot-spot fields at ×400. Groups were compared with independent-samples t tests, with Mann-Whitney U tests as sensitivity analyses, and each marker was modeled by linear regression adjusted for age, sex, and any comorbidity. The Institutional Review Board of the Medical Research Institute, Alexandria University (IORG0008812), approved the study (E/C. S/N. R06/2025).
- Conditions
- Obesity
- Being tested
- Sleeve gastrectomy, Diagnostic upper gastrointestinal endoscopy with biopsy
- Keywords
- gastric mucosa, obesity, sleeve gastrectomy, mast cells, macrophages, microvessel density, immunohistochemistry
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
Source of tissue; no study intervention. Gastric mucosa taken from the greater curvature of the mid-body of the resected specimen.
Diagnostic upper gastrointestinal endoscopy with biopsyProcedure or surgery
Source of tissue; no study intervention. At least four mucosal biopsies from the greater curvature of the mid-body.
| Study group | Role | What they receive |
|---|---|---|
| Patients with obesity (sleeve gastrectomy) | Aged 17 years or older, undergoing elective sleeve gastrectomy; gastric mucosa taken from the greater curvature of the mid-body of the resected specimen. Receives: Procedure: Sleeve gastrectomy | |
| Participants without obesity (diagnostic endoscopy) | Aged 17 years or older, BMI below 30 kg/m², endoscopy for benign indications; at least four mucosal biopsies from the greater curvature of the mid-body. Receives: Procedure: Diagnostic upper gastrointestinal endoscopy with biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tryptase-positive mast-cell density in gastric mucosa
Mast cells per high-power field (×400, about 0.24 mm²), mean of five mucosal hot spots, compared between groups.
Measured: Single assessment of the tissue obtained at surgery or endoscopy
CD68-positive macrophage count in gastric mucosa
CD68-positive macrophages per high-power field (×400, about 0.24 mm²), mean of five mucosal hot spots, compared between groups.
Measured: Single assessment of the tissue obtained at surgery or endoscopy
CD31-positive microvessel density in gastric mucosa
CD31-positive microvessels per high-power field (×400, about 0.24 mm²), mean of five mucosal hot spots, compared between groups.
Measured: Single assessment of the tissue obtained at surgery or endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Jan 2025
- Primary completion13 May 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448896
- Sponsor's protocol ID
- Mast cells obesity
- Other IDs
- E/C. S/N. R06/2025
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared on reasonable request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Mucosal Mast Cells, Macrophages and Microvessels in Patients With Obesity Undergoing Sleeve Gastrectomy: A Comparative Cross-Sectional Immunohistochemical Study
- ClinicalTrials.gov ID
- NCT07448896
- Acronym / sponsor ID
- Mast cells obesity
- Conditions
- Obesity
- Keywords
- gastric mucosa, obesity, sleeve gastrectomy, mast cells, macrophages, microvessel density, immunohistochemistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 4 Mar 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.
This comparative cross-sectional study compared tryptase-positive mast cells, CD68-positive macrophages, and CD31-positive microvessels in the gastric mucosa of 31 patients with obesity undergoing sleeve gastrectomy and 33 participants without obesity undergoing diagnostic endoscopy. Active Helicobacter pylori infection, recent smoking, and overt mucosal disease were excluded.
Detailed description
Participants were enrolled and gastric tissue was collected at the Medical Research Institute Hospital, Alexandria University, between January and December 2025. This record was first submitted on 20 February 2026, after enrollment had closed, and was updated in October 2026 so that its dates, enrollment, design and eligibility describe the completed study; the three marker outcomes were kept, and extracellular tryptase is listed as a qualitative observation. In both groups, tissue came from the greater curvature of the mid-body. A pathologist blinded to group counted each marker in five mucosal hot-spot fields at ×400. Groups were compared with independent-samples t tests, with Mann-Whitney U tests as sensitivity analyses, and each marker was modeled by linear regression adjusted for age, sex, and any comorbidity. The Institutional Review Board of the Medical Research Institute, Alexandria University (IORG0008812), approved the study (E/C. S/N. R06/2025).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with obesity (sleeve gastrectomy) | – | Procedure: Sleeve gastrectomyAged 17 years or older, undergoing elective sleeve gastrectomy; gastric mucosa taken from the greater curvature of the mid-body of the resected specimen. |
| Participants without obesity (diagnostic endoscopy) | – | Procedure: Diagnostic upper gastrointestinal endoscopy with biopsyAged 17 years or older, BMI below 30 kg/m², endoscopy for benign indications; at least four mucosal biopsies from the greater curvature of the mid-body. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with obesity undergoing elective sleeve gastrectomy and participants without obesity (BMI below 30 kg/m²) undergoing diagnostic upper gastrointestinal endoscopy at the Medical Research Institute Hospital, Alexandria University, Egypt, between January and December 2025. Of 835 candidates screened (634 for sleeve gastrectomy, 201 for endoscopy), 771 were excluded or declined, and 64 were enrolled (31 and 33).
Key inclusion criteria (4 listed)
- Cases: patients aged 17 years or older with obesity scheduled for elective sleeve gastrectomy according to the 2022 ASMBS/IFSO indications for metabolic and bariatric surgery.
- Controls: participants aged 17 years or older with BMI below 30 kg/m² undergoing diagnostic upper gastrointestinal endoscopy for benign indications, such as mild dyspepsia, with no endoscopic evidence of active gastric mucosal disease.
- Negative rapid urease test for Helicobacter pylori on antral biopsy.
- Written informed consent.
Key exclusion criteria (9 listed)
- Positive rapid urease test.
- Active erosive gastritis, peptic ulcer disease, or suspected or confirmed gastric malignancy at endoscopy.
- Current cigarette smoking, or smoking cessation within 6 months before enrollment.
- Prior gastric surgery.
- Secondary causes of obesity, such as Cushing's syndrome or hypothyroidism.
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 |
|---|---|---|
| Sleeve gastrectomySource of tissue; no study intervention. Gastric mucosa taken from the greater curvature of the mid-body of the resected specimen. | Procedure or surgery | Patients with obesity (sleeve gastrectomy) |
| Diagnostic upper gastrointestinal endoscopy with biopsySource of tissue; no study intervention. At least four mucosal biopsies from the greater curvature of the mid-body. | Procedure or surgery | Participants without obesity (diagnostic endoscopy) |
Primary outcome
Tryptase-positive mast-cell density in gastric mucosa
Time frame: Single assessment of the tissue obtained at surgery or endoscopy
Mast cells per high-power field (×400, about 0.24 mm²), mean of five mucosal hot spots, compared between groups.
CD68-positive macrophage count in gastric mucosa
Time frame: Single assessment of the tissue obtained at surgery or endoscopy
CD68-positive macrophages per high-power field (×400, about 0.24 mm²), mean of five mucosal hot spots, compared between groups.
CD31-positive microvessel density in gastric mucosa
Time frame: Single assessment of the tissue obtained at surgery or endoscopy
CD31-positive microvessels per high-power field (×400, about 0.24 mm²), mean of five mucosal hot spots, compared between groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared on reasonable request to the principal investigator.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 9 Oct 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tryptase-positive mast-cell density in gastric mucosa (time frame: Single assessment of the tissue obtained at surgery or endoscopy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.