Health TrialsbyHealthPanel

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

ConditionMetabolic Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorCenter of New Medical Technologies

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Verified MS per NCEP-ATP III criteria.

Ability to undergo all procedures (fasting blood draw, breath test, stool antigen, endoscopy/biopsy, anthropometry).

Disqualifiers

Current metabolic-influencing therapy.

Acute/chronic infection or autoimmune flare.

Interventional study participation in last 3 months.

Planned surgery/long hospitalization.

Trial population

Patients with metabolic syndrome

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: group with persistence of H. pylori
Group B: group without persistence of H. pylori

Trial outcomes

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

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

Secondary outcomes

1

CRP level differences

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

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

difference in body mass index levels

any differences between groups in terms of body mass index (kg/m²)

Time frame
No more than 2 days from the date of inclusion in the study
3

difference in waist circumference

any differences between groups in waist circumference (cm)

Time frame
No more than 2 days from the date of inclusion in the study
4

difference in fasting glucose levels

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center of New Medical Technologies

Lead sponsor

Novosibirsk State University

Collaborator

Source ClinicalTrials.gov
Apply now