Metabolic Syndrome
Conditions
Keywords
insulin resistance, HOMA-IR, Helicobacter pylori, inflammation of the gastrointestinal mucosa
Brief summary
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.
Interventions
None listed
Sponsors
Center of New Medical Technologies
Novosibirsk State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in HOMA-IR index between H. pylori-positive and -negative patients. | No more than 2 days after inclusion in the study | Any difference between groups according to the HOMA-IR index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRP level differences | No more than 2 days from the date of inclusion in the study | any differences between groups in C-reactive protein levels (mg/L) |
| difference in body mass index levels | No more than 2 days from the date of inclusion in the study | any differences between groups in terms of body mass index (kg/m²) |
| difference in waist circumference | No more than 2 days from the date of inclusion in the study | any differences between groups in waist circumference (cm) |
| difference in fasting glucose levels | No more than 2 days from the date of inclusion in the study | any differences between groups in fasting glucose levels (mmol/L) |
| difference in triglyceride levels | No more than 2 days from the date of inclusion in the study | any differences between groups in triglyceride levels (mmol/L) |
| difference in total cholesterol levels | No more than 2 days from the date of inclusion in the study | any differences between groups in total cholesterol levels (mmol/L) |
| difference in low-density lipoprotein levels | No more than 2 days from the date of inclusion in the study | any differences between groups in low-density lipoprotein levels (mmol/L) |
| difference in high-density lipoprotein levels | No more than 2 days from the date of inclusion in the study | any differences between groups in high-density lipoprotein levels (mmol/L) |
| difference in the atherogenic index | No more than 2 days from the date of inclusion in the study | any differences between groups in atherogenic index |
Countries
Russia
Contacts
CONTACTEvgeniya V Shrainer, PhD
CONTACTElizaveta K Nemkova, MD
Outcome results
None listed