Assessing the Association Between H. Pylori Persistence and the Severity of Insulin Resistance in Patients With Metabolic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing the Association Between H. Pylori Persistence and the Severity of Insulin Resistance in Patients With Metabolic Syndrome Cohort Observational Study
Overview
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.
Detailed 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.
Primary outcome measures
- Difference in HOMA-IR index between H. pylori-positive and -negative patients. [Time frame: No more than 2 days after inclusion in the study]
Secondary outcome measures (9)
- CRP level differences [Time frame: No more than 2 days from the date of inclusion in the study]
- difference in body mass index levels [Time frame: No more than 2 days from the date of inclusion in the study]
- difference in waist circumference [Time frame: No more than 2 days from the date of inclusion in the study]
- difference in fasting glucose levels [Time frame: No more than 2 days from the date of inclusion in the study]
- difference in triglyceride levels [Time frame: No more than 2 days from the date of inclusion in the study]
- difference in total cholesterol levels [Time frame: No more than 2 days from the date of inclusion in the study]
- difference in low-density lipoprotein levels [Time frame: No more than 2 days from the date of inclusion in the study]
- difference in high-density lipoprotein levels [Time frame: No more than 2 days from the date of inclusion in the study]
- difference in the atherogenic index [Time frame: No more than 2 days from the date of inclusion in the study]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Center of New Medical Technologies — Novosibirsk
Identifiers
NCT: NCT07501858 · CNMT004