[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489346":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":10,"centralContacts":43,"locations":54,"responsibleParty":83,"collaborators":10,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":10,"studyType":99,"phases":10,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,16,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"No-T2D +MS \u002F No-HF (control group)",null,"50 patients without T2D +MS and without Heart Failure will be included in group 1.",[13,14,15],"Biological: Blood test","Behavioral: quality of life Questionnaire","Behavioral: Diet habits questionnaire",{"label":17,"type":10,"description":18,"interventionNames":19},"No-T2D +MS \u002F HFpEF or HFmrEF","25 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"T2D+MS \u002F no-HF","50 patients presenting T2D +MS and without any type of HF will be included in group 3.",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"T2D +MS \u002F HFpEF or HFmrEF","50 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.",[13,14,15],[29,34,39],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"BIOLOGICAL","Blood test","During the routine blood test of the patient, 4 more tubes of 4 milliliters (mL) will be collected to make a biological collection of PBMC and plasma for further analysis.",[17,9,25,21],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"BEHAVIORAL","quality of life Questionnaire","During the routine medical visit, the patient will be asked to fill in a short questionnaire about quality of life.\n\nThis is a descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression. Each dimension has 3 levels: no problems, some problems, and extreme problems. This decision results into a 1-digit number that expresses the level selected for that dimension. Each patient's health state is referred to in terms of a 5-digit code;\n\nLevels of perceived problems are coded as follows:\n\n* Level 1 is coded as a '1' (indicating no problem)\n* Level 2 is coded as a '2' (indicating some problems)\n* Level 3 is coded as a '3' (indicating extreme problems) For example, state 11223 indicates no problems with mobility and self-care, no problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression, while state 11111 indicates no problems.",[17,9,25,21],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"Diet habits questionnaire","During the routine medical visit, the patient will be asked to fill in a short questionnaire about his diet habits.\n\nThis is an exploratory questionnaire that describes and quantifies the foods (pro- or anti-inflammatory) ingested by patients.",[17,9,25,21],[44,50],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"Hélène THIBAULT, PU,PH","CONTACT","0427856691","+33","Helene.thibault@chu-lyon.fr",{"name":51,"role":46,"phone":52,"phoneExt":48,"email":53},"Julia CANTERINI","0427856628","Julia.canterini@chu-lyon.fr",[55],{"facility":56,"status":57,"city":58,"state":10,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Hopital Louis Pradel","RECRUITING","Bron","69677","France","FR",{"type":63,"coordinates":64},"Point",[65,66],4.91303,45.73865,{"lat":66,"lon":65},[69,72,74,77,79,81],{"name":70,"role":46,"phone":71,"phoneExt":48,"email":49},"Hélène Thibault, PU,PH","04427856691",{"name":70,"role":73,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":75,"role":76,"phone":10,"phoneExt":10,"email":10},"Cyrille BERGEROT, MD, PhD","SUB_INVESTIGATOR",{"name":78,"role":76,"phone":10,"phoneExt":10,"email":10},"Sybil CHARRIERE, PU,PH",{"name":80,"role":76,"phone":10,"phoneExt":10,"email":10},"Laurent SEBBAG, PU,PH",{"name":82,"role":76,"phone":10,"phoneExt":10,"email":10},"Nathan MEWTON, PU,PH",{"type":84,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100489346","pbmc-as-biomarkers-of-diabetic-cardiomyopathy-100489346",false,"NCT05651919","PBMC as Biomarkers of Diabetic Cardiomyopathy","Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy","MOBI","Inclusion Criteria:\n\nInclusion criteria common to the 4 groups:\n\n* Patient attending a scheduled cardiology or endocrinology follow-up visit\n* Patient fasting for blood sampling\n* Male or female aged 40 to 85 years inclusive\n* Patient not opposing participation in this research\n* Patient agreeing to the storage of biological samples and to genetic analyses\n\nGroup 1: No-T2D +MS \u002F No-HF (control group)\n\n\\- Patient without T2D or MS and without heart failure coming to a consultation or day hospital for another reason (e.g. screening for atypical symptom, etc.)\n\nGroup 2: No-T2D +MS \u002F HFpEF or HFmrEF\n\n* Patient without T2D or MS\n* HFpEF or HFmrEF. diagnosed\n\nGroup 3: T2D+MS \u002F no-HF\n\n* Patient diagnosed with T2D+MS\n* \\- Absence of HF\n\nGroup 4: T2D +MS \u002F HFpEF or HFmrEF\n\n* Patient diagnosed with T2D and MS\n* HFpEF or HFmrEF. diagnosed\n\nExclusion Criteria:\n\nNon-inclusion criteria common to the 4 groups:\n\n* History of cardiovascular disease (valvular disease \\[greater than moderate severity\\], radiation-induced, post-cardiotoxic chemotherapy, amyloidosis, etc.) other than HFpEF or HFmrEF\n* Acute or ongoing systemic inflammatory or infectious disease\n* History of known coronary artery disease\n* Uncontrolled hypertension (\\>160\u002F100 mmHg)\n* Pregnant or breastfeeding women (based on interview)\n* Persons deprived of liberty by judicial or administrative decision\n* Persons undergoing psychiatric care\n* Patient under legal protection (guardianship or curatorship)\n* Subject participating in another interventional study with an ongoing exclusion period\n* Chronic kidney disease (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n\nGroup 1: No-T2D +MS \u002F No-HF (control group)\n\n* Presence of diabetes (whatever the type) and MS\n* Presence of heart failure or other known heart disease\n\nGroup 2: No-T2D +MS \u002F HFpEF or HFmrEF\n\n* Presence of diabetes (whatever the type) and MS\n* Left Ventricular Ejection Fraction (LVEF) on ultrasound ≤ 40%\n\nGroup 3: T2D+MS \u002F no-HF\n\n* Without diabetes or other type of diabetes than T2D\n* Presence of Heart failure (all types)\n\nGroup 4: T2D +MS \u002F HFpEF or HFmrEF\n\n* Absence of diabetes or presence of another type of diabetes than T2D\n* LVEF on ultrasound ≤ 40%","ALL","40 Years","85 Years",{"count":97,"type":98},175,"ESTIMATED","OBSERVATIONAL","Type 2 diabetes (T2D), especially when associated with metabolic syndrome (MS) is at high risk to develop heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF), and the specific impact of T2D+MS in cardiac function impairment is usually known as \"diabetic cardiomyopathy\" (DC). Cardiac remodelling (ie hypertrophy) and subtle myocardial dysfunction are highly prevalent in T2D+MS but not specific enough to predict further HFpEF or HFmrEF. Also, current biomarkers can identify but do not predict HFpEF or HFmrEF in T2D patients; Furthermore, specific biomarkers are needed. Peripheral blood mononuclear cells (PBMC) obtained from a peripheral blood sample can provide insights from calcic and inflammatory pathways, and may identify more specific molecular signatures shared between T2D+MS and HFpEF.",[102,103,104,105],"Type 2 Diabetes","Metabolic Syndrome","Heart Failure With Preserved Ejection Fraction","Heart Failure With Mildly Reduced Ejection Fraction",[107,108,109,110,111],"Type 2 diabetes","metabolic syndrome","Heart Failure with Preserved Ejection Fraction","heart failure with mildly reduced ejection fraction","PBMC","2026-03-23",{"date":114,"type":115},"2026-03-27","ACTUAL",{"date":117,"type":115},"2023-05-23",{"date":119,"type":98},"2028-05-23",{"name":5,"class":6},1]