Metabolic SyndromeNCT07501858
Assessing the Association Between H. Pylori Persistence and the Severity of Insulin Resistance in Patients With Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Center of New Medical Technologies at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metabolic syndrome
Who may be able to join
- Verified MS per NCEP-ATP III criteria.
- Ability to undergo all procedures (fasting blood draw, breath test, stool antigen, endoscopy/biopsy, anthropometry).
Who cannot join
- 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.
Show all 9Show fewer
- Pregnancy/lactation.
- Gastric resection or upper GI reconstruction.
- Type 1 diabetes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Center of New Medical Technologies
Novosibirsk, Novosibirsk Oblast, 630090
Andrey V Ponomarenko, MD, 9628316017 ext. +7, ponomarenko_av@cnmt.ru
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Keywords
- insulin resistance, HOMA-IR, Helicobacter pylori, inflammation of the gastrointestinal mucosa
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Difference in HOMA-IR index between H. pylori-positive and -negative patients.
Any difference between groups according to the HOMA-IR index
Measured: No more than 2 days after inclusion in the study
Secondary outcomes (9)
CRP level differences
any differences between groups in C-reactive protein levels (mg/L)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: No more than 2 days from the date of inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center of New Medical Technologies
- Sponsor type
- University, hospital or other
- Collaborators
- Novosibirsk State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501858
- Sponsor's protocol ID
- CNMT004
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Association Between H. Pylori Persistence and the Severity of Insulin Resistance in Patients With Metabolic Syndrome Cohort Observational Study
- ClinicalTrials.gov ID
- NCT07501858
- Acronym / sponsor ID
- CNMT004
- Conditions
- Metabolic Syndrome
- Keywords
- insulin resistance, HOMA-IR, Helicobacter pylori, inflammation of the gastrointestinal mucosa
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Center of New Medical TechnologiesUniversity, hospital or other
- Collaborators
- Novosibirsk State University
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metabolic syndrome
Key inclusion criteria (2 listed)
- Verified MS per NCEP-ATP III criteria.
- Ability to undergo all procedures (fasting blood draw, breath test, stool antigen, endoscopy/biopsy, anthropometry).
Key exclusion criteria (9 listed)
- Current metabolic-influencing therapy.
- Acute/chronic infection or autoimmune flare.
- Interventional study participation in last 3 months.
- Planned surgery/long hospitalization.
- Active malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
CRP level differences
Time frame: No more than 2 days from the date of inclusion in the study
difference in body mass index levels
Time frame: No more than 2 days from the date of inclusion in the study
difference in waist circumference
Time frame: No more than 2 days from the date of inclusion in the study
difference in fasting glucose levels
Time frame: No more than 2 days from the date of inclusion in the study
difference in triglyceride levels
Time frame: No more than 2 days from the date of inclusion in the study
difference in total cholesterol levels
Time frame: No more than 2 days from the date of inclusion in the study
difference in low-density lipoprotein levels
Time frame: No more than 2 days from the date of inclusion in the study
difference in high-density lipoprotein levels
Time frame: No more than 2 days from the date of inclusion in the study
difference in the atherogenic index
Time frame: No more than 2 days from the date of inclusion in the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Center of New Medical Technologies at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evgeniya V Shrainer, PhD (983 300 22 05 ext. +7, shrayner_ev@cnmt.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in HOMA-IR index between H. pylori-positive and -negative patients. (time frame: No more than 2 days after inclusion in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.