Clinical trial NCT06935955: Helicobacter Pylori Gastritis and Its Relation to Metabolic Syndrome Components
Official title: Helicobacter Pylori Gastritis and Its Relation to Metabolic Syndrome Components
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 2.2 Aim

1. To evaluate the association between H. pylori infection and the components of metabolic syndrome.
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.

2.4. 2- Study Setting: Department of Pathology, Faculty of Medicine, Assiut University.

c. Sample Size Calculation: Sample size was calculated using Epi- Info7. Based on The H. pylori-positive patients were more likely to develop dyslipidemia, and 77.47% of individuals testing positive for H. pylori have higher total cholesterol levels (11). With a confidence limit of 5% and a confidence level of 80%, the minimum number of patients required for this study is 114 cases

2.4.4 -Study tools The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy. Written informed consent will be obtained from all patients participating in the study.

All subjects will be asked to complete a medical history questionnaire, followed by a 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, and it will assess chronic and acute gastritis, atrophic gastritis, and metaplasia. The endoscopist will obtain five biopsy samples: two from the antrum, two from the corpus, and one from the incisura.

All biopsies will be processed at the Pathology Department laboratory and embedded in paraffin blocks. For histological examination, two tissue sections will be stained: hematoxylin and eosin (H\&E) and Giemsa stain. Each sample will undergo a double-blind review by two independent pathologists according to the USS (HP, neutrophils, mononuclear cells, atrophy, and intestinal metaplasia), and each variable will be graded semi-quantitatively.

Statistical analysis using suitable tests will be used to assess our results.

2.4.5 -Research outcome measures:

1. Primary (main): to evaluate the association between H.pylori gastritis and its relation to metabolic syndrome components
2. Secondary (subsidiary):

2.5-Data management and analysis : Data collection All subjects will be asked to complete a medical history questionnaire, followed by a 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.

Computer software Statistical package for social science (SPSS) program v. 25 (IBM, August 2017).


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and above with dyspeptic symptoms

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Dyslipidemia
timeFrame: periprocedural
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: