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

NCT07501858 | Recruiting

• 1 other identifier: CNMT004
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

insulin resistance; HOMA-IR; Helicobacter pylori; inflammation of the gastrointestinal mucosa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• CRP level differences

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

• difference in body mass index levels

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

• difference in waist circumference

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

• difference in fasting glucose levels

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

• difference in triglyceride levels

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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metabolic syndrome

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center of New Medical Technologies: lead
• Novosibirsk State University: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibirsk Oblast, 630090, Russia

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Evgeniya V Shrainer, PhD

CONTACT

983 300 22 05; shrayner_ev@cnmt.ru

Elizaveta K Nemkova, MD

CONTACT

9512732447; nemkova_ek@cnmt.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)