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NCT Number: NCT07501858

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

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibirsk Oblast, 630090, Russia

Location status: Recruiting

Location contact

Andrey V Ponomarenko, MD

CONTACT

[email protected]

9628316017 ext. +7

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Difference in HOMA-IR index between H. pylori-positive and -negative patients.

    Time frame: No more than 2 days after inclusion in the study

    Any difference between groups according to the HOMA-IR index

Secondary outcomes

  1. CRP level differences

    Time frame: No more than 2 days from the date of inclusion in the study

    any differences between groups in C-reactive protein levels (mg/L)

  2. difference in body mass index levels

    Time frame: 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)

  3. difference in waist circumference

    Time frame: No more than 2 days from the date of inclusion in the study

    any differences between groups in waist circumference (cm)

  4. difference in fasting glucose levels

    Time frame: No more than 2 days from the date of inclusion in the study

    any differences between groups in fasting glucose levels (mmol/L)

  5. difference in triglyceride levels

    Time frame: No more than 2 days from the date of inclusion in the study

    any differences between groups in triglyceride levels (mmol/L)

  6. difference in total cholesterol levels

    Time frame: No more than 2 days from the date of inclusion in the study

    any differences between groups in total cholesterol levels (mmol/L)

  7. difference in low-density lipoprotein levels

    Time frame: No more than 2 days from the date of inclusion in the study

    any differences between groups in low-density lipoprotein levels (mmol/L)

  8. difference in high-density lipoprotein levels

    Time frame: No more than 2 days from the date of inclusion in the study

    any differences between groups in high-density lipoprotein levels (mmol/L)

  9. difference in the atherogenic index

    Time frame: No more than 2 days from the date of inclusion in the study

    any differences between groups in atherogenic index

Study contacts

Contact information is provided by the study sponsor or research team.

Elizaveta K Nemkova, MD

CONTACT

[email protected]

9512732447 ext. +7

Evgeniya V Shrainer, PhD

CONTACT

[email protected]

983 300 22 05 ext. +7

Sponsors and collaborators

Lead sponsor

Center of New Medical Technologies

Other

Collaborators

  • Novosibirsk State University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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