H. pylori and insulin resistance in people 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 project will test whether people with metabolic syndrome who still have H. pylori infection have worse insulin resistance (measured by HOMA-IR) than similar patients without the infection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Center of New Medical Technologies Academic / other |
| Locations | 1 site (Novosibirsk, Novosibirsk Oblast) |
| Trial ID | NCT07501858 on ClinicalTrials.gov |
What this trial studies
This retrospective cohort review uses medical records from 100 patients with metabolic syndrome seen at the Center for New Medical Technologies in Novosibirsk. Patients are divided into two groups of 50 with and without confirmed H. pylori infection based on breath test, stool antigen, or biopsy results, and fasting labs and metabolic parameters were extracted. The primary endpoint is the difference in HOMA-IR between the infected and non-infected groups; secondary analyses examine correlations between infection persistence, markers of gastric inflammation (gastro panel, CRP), and other metabolic markers. Statistical comparisons and correlation analyses will determine whether persistent H. pylori infection is linked to greater insulin resistance.
Who should consider this trial
Good fit: Ideal candidates are adults with confirmed metabolic syndrome by NCEP-ATP III who received gastrointestinal testing and have fasting laboratory data available to calculate HOMA-IR at the CNMT site.
Not a fit: Patients without metabolic syndrome, those lacking H. pylori testing or fasting labs, or those currently on therapies that substantially alter metabolic measures are unlikely to gain from this analysis.
Why it matters
Potential benefit: If a clear link is found, identifying and treating persistent H. pylori could become a target to help improve insulin resistance and reduce metabolic complications.
How similar studies have performed: Previous meta-analyses and cohort studies have reported an association between H. pylori infection and increased risk of metabolic syndrome and insulin resistance, but evidence on whether eradication improves metabolic measures is mixed.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Novosibirsk, Novosibirsk Oblast
- Center of New Medical Technologies — Novosibirsk, Novosibirsk Oblast, Russia (Recruiting)
Study contacts
- Study coordinator: Evgeniya V Shrainer, PhD
- Email: shrayner_ev@cnmt.ru
- Phone: 983 300 22 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.