[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631528":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":46,"studyPopulation":47,"armGroups":48,"interventions":42,"overallOfficials":42,"centralContacts":55,"locations":66,"responsibleParty":85,"collaborators":87,"id":90,"slug":42,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":42,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":42,"studyType":102,"phases":42,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":68,"whyStopped":42,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Center of New Medical Technologies","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,21,24,27,30,33,36,39],{"measure":15,"description":16,"timeFrame":17},"CRP level differences","any differences between groups in C-reactive protein levels (mg\u002FL)","No more than 2 days from the date of inclusion in the study",{"measure":19,"description":20,"timeFrame":17},"difference in body mass index levels","any differences between groups in terms of body mass index (kg\u002Fm²)",{"measure":22,"description":23,"timeFrame":17},"difference in waist circumference","any differences between groups in waist circumference (cm)",{"measure":25,"description":26,"timeFrame":17},"difference in fasting glucose levels","any differences between groups in fasting glucose levels (mmol\u002FL)",{"measure":28,"description":29,"timeFrame":17},"difference in triglyceride levels","any differences between groups in triglyceride levels (mmol\u002FL)",{"measure":31,"description":32,"timeFrame":17},"difference in total cholesterol levels","any differences between groups in total cholesterol levels (mmol\u002FL)",{"measure":34,"description":35,"timeFrame":17},"difference in low-density lipoprotein levels","any differences between groups in low-density lipoprotein levels (mmol\u002FL)",{"measure":37,"description":38,"timeFrame":17},"difference in high-density lipoprotein levels","any differences between groups in high-density lipoprotein levels (mmol\u002FL)",{"measure":40,"description":41,"timeFrame":17},"difference in the atherogenic index","any differences between groups in atherogenic index",null,{"allocation":42,"interventionModel":42,"interventionModelDescription":42,"primaryPurpose":42,"observationalModel":44,"timePerspective":45,"maskingInfo":42},"COHORT","PROSPECTIVE","This retrospective cohort study evaluates the association between H. pylori persistence and insulin resistance severity.\n\nRelevance 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.\n\nChronic 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.\n\nHypothesis, Aim, and Objectives Hypothesis: Chronic inflammation from H. pylori exacerbates systemic inflammation and deteriorates metabolic parameters, including IR indices.\n\nPrimary Aim: Establish the presence and nature of correlation between H. pylori persistence and IR severity (via HOMA-IR) in verified MS patients.","Patients with metabolic syndrome",[49,52],{"label":50,"type":42,"description":51,"interventionNames":42},"group with persistence of H. pylori","group with metabolic syndrome and persistence of H. pylori",{"label":53,"type":42,"description":54,"interventionNames":42},"group without persistence of H. pylori","group without metabolic syndrome and persistence of H. pylori",[56,62],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Evgeniya V Shrainer, PhD","CONTACT","983 300 22 05","+7","shrayner_ev@cnmt.ru",{"name":63,"role":58,"phone":64,"phoneExt":60,"email":65},"Elizaveta K Nemkova, MD","9512732447","nemkova_ek@cnmt.ru",[67],{"facility":5,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"RECRUITING","Novosibirsk","Novosibirsk Oblast","630090","Russia","RU",{"type":75,"coordinates":76},"Point",[77,78],82.93175,55.02259,{"lat":78,"lon":77},[81],{"name":82,"role":58,"phone":83,"phoneExt":60,"email":84},"Andrey V Ponomarenko, MD","9628316017","ponomarenko_av@cnmt.ru",{"type":86,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[88],{"name":89,"class":6},"Novosibirsk State University","100631528",false,"NCT07501858","Assessing the Association Between H. Pylori Persistence and the Severity of Insulin Resistance in Patients With Metabolic Syndrome","Assessing the Association Between H. Pylori Persistence and the Severity of Insulin Resistance in Patients With Metabolic Syndrome Cohort Observational Study","Inclusion Criteria:\n\n* Verified MS per NCEP-ATP III criteria.\n* Ability to undergo all procedures (fasting blood draw, breath test, stool antigen, endoscopy\u002Fbiopsy, anthropometry).\n\nExclusion Criteria:\n\n* Current metabolic-influencing therapy.\n* Acute\u002Fchronic infection or autoimmune flare.\n* Interventional study participation in last 3 months.\n* Planned surgery\u002Flong hospitalization.\n* Active malignancies.\n* Severe liver\u002Fkidney failure.\n* Pregnancy\u002Flactation.\n* Gastric resection or upper GI reconstruction.\n* Type 1 diabetes.","ALL","18 Years","65 Years",{"count":100,"type":101},100,"ESTIMATED","OBSERVATIONAL","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.",[105],"Metabolic Syndrome",[107,108,109,110],"insulin resistance","HOMA-IR","Helicobacter pylori","inflammation of the gastrointestinal mucosa","2026-03-24",{"date":113,"type":114},"2026-03-30","ACTUAL",{"date":116,"type":101},"2026-04-01",{"date":118,"type":101},"2028-07-01",{"name":5,"class":6},1]