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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Evgeniya V Shrainer, PhD; Phone Number: +7 983 300 22 05; Email: shrayner_ev@cnmt.ru
• Study Contact Backup: Name: Elizaveta K Nemkova, MD; Phone Number: +7 9512732447; Email: nemkova_ek@cnmt.ru

Study Locations

• Russia
  • Novosibirsk Oblast
    • Novosibirsk, Novosibirsk Oblast, Russia, 630090
      • Recruiting
      • Center of New Medical Technologies
      • Contact: Andrey V Ponomarenko, MD; Phone Number: +7 9628316017; Email: ponomarenko_av@cnmt.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with metabolic syndrome

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
group with persistence of H. pylori; group with metabolic syndrome and persistence of H. pylori
group without persistence of H. pylori; group without metabolic syndrome and persistence of H. pylori

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in HOMA-IR index between H. pylori-positive and -negative patients.	Any difference between groups according to the HOMA-IR index	No more than 2 days after inclusion in the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRP level differences	any differences between groups in C-reactive protein levels (mg/L)	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)	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)	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)	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)	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)	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)	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)	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	No more than 2 days from the date of inclusion in the study

Collaborators and Investigators

• Sponsor: Center of New Medical Technologies
• Collaborators: Novosibirsk State University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Helicobacter pylori; insulin resistance; HOMA-IR; inflammation of the gastrointestinal mucosa
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Nutritional and Metabolic Diseases; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: CNMT004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No