Assessing the Association Between H. Pylori Persistence and the Severity of Insulin Resistance in Patients With Metabolic Syndrome

Center of New Medical Technologies

Status: Enrolling

Conditions: Metabolic Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT07501858

CNMT004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Verified MS per NCEP-ATP III criteria.
• Ability to undergo all procedures (fasting blood draw, breath test, stool antigen, endoscopy/biopsy, anthropometry).

Exclusion criteria

• Current metabolic-influencing therapy.
• Acute/chronic infection or autoimmune flare.
• Interventional study participation in last 3 months.
• Planned surgery/long hospitalization.
• Active malignancies.
• Severe liver/kidney failure.
• Pregnancy/lactation.
• Gastric resection or upper GI reconstruction.
• Type 1 diabetes.

Trial design

100 participants in 2 patient groups

group with persistence of H. pylori

Description:

group with metabolic syndrome and persistence of H. pylori

group without persistence of H. pylori

Description:

group without metabolic syndrome and persistence of H. pylori