Helicobacter Pylori Gastritis and Its Relation to Metabolic Syndrome Components

NCT06935955 | Not Yet Recruiting

• 1 other identifier: Helicobacter Pylori Gastritis
• Study Type: observational
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief Summary

2.2 Aim

1. 1.To evaluate the association between H. pylori infection and the components of metabolic syndrome.
2. 2.To assess the relationship between the histopathologic features of chronic gastritis evaluated using USS and the components of metabolic syndrome in both H. pylori-positive and H. pylori-negative patients.
3. 3.Primary (main): to evaluate the association between H.pylori gastritis and its relation to metabolic syndrome components
4. 4.Secondary (subsidiary):

Conditions

Gastritis

Outcome Measures

Primary Outcomes (1)

• Dyslipidemia

  we will measure Low-density lipoprotein and serum cholesterol as a marker of dyslipidemia

  periprocedural

Study Arms (1)

cohort 1 gastritis patients

The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy

Diagnostic Test: upper endoscopy

Interventions

upper endoscopy DIAGNOSTIC_TEST

All subjects will be asked to complete a medical history questionnaire, followed by physical examination (height, body weight, waist circumference and blood pressure), and laboratory investigations (fasting blood glucose, liver function test, total cholesterol, triglycerides, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol( The endoscopy will be carried out by the same specialist, with assessment of chronic and acute gastritis, atrophic gastritis and metaplasia. The endoscopist will obtain five biopsies samples, two from the antrum, two from the corpus and one from incisura. All biopsies will be processed at the Pathology Department laboratory and embedded in paraffin blocks. For histological examination, two sets of tissue sections will be stained: one with hematoxylin and eosin (H\&E) and the other with Giemsa stain. Each sample will undergo a double-blind review by two independent pathologists according to the USS (HP, neutrophils, mononuclear cells, atro

cohort 1 gastritis patients

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

The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy.

You may qualify if:

• Patients aged 18 years and above with dyspeptic symptoms

You may not qualify if:

• People who have a history of H.Pylori eradication or gastric surgery.
• Those who have already received anti-cholesterol therapy.
• Those suffering from severe liver disease, severe kidney disease, or cancer.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Gastritis

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 20, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-04