This retrospective cohort study evaluates the association between H. pylori persistence and insulin resistance severity (HOMA-IR) in 100 patients with metabolic syndrome at Novosibirsk's Center for New Medical Technologies (CNMT). Patients are divided into infected (n=50) and non-infected (n=50) groups, assessing metabolic parameters, gastro panel, and CRP. Primary endpoint: HOMA-IR differences; secondary: correlations with gastric inflammation and metabolic markers.
This retrospective cohort study evaluates the association between H. pylori persistence and insulin resistance severity. Relevance Metabolic syndrome (MS) is a major public health issue due to its high prevalence and role in type 2 diabetes, non-alcoholic fatty liver disease, and cardiovascular diseases. Insulin resistance (IR) is a key pathogenetic factor in MS. Recent meta-analyses confirm a significant association between H. pylori infection and increased MS and IR risk, highlighting the need to explore H. pylori's role in metabolic disorders. Chronic H. pylori-induced inflammation may promote low-grade systemic inflammation, worsening carbohydrate metabolism, supported by meta-analytic and cohort studies. Elevated pro-inflammatory cytokines and C-reactive protein (CRP) act as mediators of insulin sensitivity impairment. H. pylori eradication effects on metabolic parameters vary, necessitating clarification of infection persistence's impact on IR in MS patients. Hypothesis, Aim, and Objectives Hypothesis: Chronic inflammation from H. pylori exacerbates systemic inflammation and deteriorates metabolic parameters, including IR indices. Primary Aim: Establish the presence and nature of correlation between H. pylori persistence and IR severity (via HOMA-IR) in verified MS patients.
Study Type
OBSERVATIONAL
Enrollment
100
Center of New Medical Technologies
Novosibirsk, Novosibirsk Oblast, Russia
RECRUITINGDifference in HOMA-IR index between H. pylori-positive and -negative patients.
Any difference between groups according to the HOMA-IR index
Time frame: No more than 2 days after inclusion in the study
CRP level differences
any differences between groups in C-reactive protein levels (mg/L)
Time frame: No more than 2 days from the date of inclusion in the study
difference in body mass index levels
any differences between groups in terms of body mass index (kg/m²)
Time frame: No more than 2 days from the date of inclusion in the study
difference in waist circumference
any differences between groups in waist circumference (cm)
Time frame: No more than 2 days from the date of inclusion in the study
difference in fasting glucose levels
any differences between groups in fasting glucose levels (mmol/L)
Time frame: No more than 2 days from the date of inclusion in the study
difference in triglyceride levels
any differences between groups in triglyceride levels (mmol/L)
Time frame: No more than 2 days from the date of inclusion in the study
difference in total cholesterol levels
any differences between groups in total cholesterol levels (mmol/L)
Time frame: No more than 2 days from the date of inclusion in the study
difference in low-density lipoprotein levels
any differences between groups in low-density lipoprotein levels (mmol/L)
Time frame: No more than 2 days from the date of inclusion in the study
difference in high-density lipoprotein levels
any differences between groups in high-density lipoprotein levels (mmol/L)
Time frame: No more than 2 days from the date of inclusion in the study
difference in the atherogenic index
any differences between groups in atherogenic index
Time frame: No more than 2 days from the date of inclusion in the study
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