[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543779":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":52,"responsibleParty":83,"collaborators":31,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":31,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":55,"whyStopped":31,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy volunters","ACTIVE_COMPARATOR","Voluntary participants with no chronic diseases aged 40 to 75 wishing to take part in the study and benefit from an exercise test.",[13,14,15],"Diagnostic Test: Exercise test","Diagnostic Test: Blood sample","Diagnostic Test: Impedancemetry",{"label":17,"type":10,"description":18,"interventionNames":19},"Metabolic syndrome patients","Patients aged 40 to 75 with metabolic syndrome undergoing functional assessment in the physiology department.",[13,14,15],{"label":21,"type":22,"description":23,"interventionNames":24},"CKD dialysis patients","EXPERIMENTAL","Chronic renal failure patients on dialysis, stable hemodialysis for more than 3 months",[13,14,15],[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIAGNOSTIC_TEST","Exercise test","\"Metabolic\" effort test on cycloergometer with gas measurement. Gas exchanges (V'O2 and V'CO2) will be measured cycle-by-cycle using a gas analyzer connected to a flow meter Measurements will be taken every 6 minutes, at rest and during exercise on a cycloergometer, in five 6-minute increments, corresponding to intensities of 0% (rest), 20%, 30%, 40%, 50 and 60% of the subject's estimated maximum power, for a total duration of around 45 minutes.",[21,9,17],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Blood sample","A catheter will be placed in a forearm vein to take blood samples at rest and at the end of the 5-stage stress test.\n\nSampling times synchronized with stress test measurements",[21,9,17],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Impedancemetry","measurement of anthropometric data (weight, height, waist circumference). impedancemetry will enable body composition to be analyzed by placing surface electrodes on the body. The participant will lie on an examination table and must remain at rest for 5 minutes.",[21,9,17],[41],{"name":42,"affiliation":5,"role":43},"GRILLET Pierre-Edouard, Pharma D. PhD","STUDY_DIRECTOR",[45,50],{"name":42,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","04 67 33 63 81","+33","pe-grillet@chu-montpellier.fr",{"name":51,"role":46,"phone":31,"phoneExt":31,"email":31},"FARES GOUZI, MD PhD",[53,71],{"facility":54,"status":55,"city":56,"state":31,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie","RECRUITING","Montpellier","34295","France","FR",{"type":61,"coordinates":62},"Point",[63,64],3.87635,43.61093,{"lat":64,"lon":63},[67],{"name":68,"role":46,"phone":69,"phoneExt":31,"email":70},"Jean-Paul CRISTOL, Prof","+33(0)4 67 33 83 15","jp-cristol@chu-montpellier.fr",{"facility":72,"status":55,"city":56,"state":31,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Montpellier University Hospital",{"type":61,"coordinates":74},[63,64],{"lat":64,"lon":63},[77,81],{"name":78,"role":46,"phone":79,"phoneExt":31,"email":80},"Farès GOUZI, MD, PhD","+33 467 335 908","f-gouzi@chu-montpellier.fr",{"name":82,"role":46,"phone":31,"phoneExt":31,"email":31},"Farès GOUZI",{"type":84,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100543779","plasma-biomarkers-of-muscle-metabolism-during-exercise-to-the-assessment-of-insulin-resistance-in-ckd-dialysis-patients-100543779",false,"NCT06360302","Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients","Contribution of Plasma Assays of Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in Chronic Renal Failure Patients Undergoing Hemodialysis.","KREBSome-IRC","Inclusion Criteria:\n\nGroup 1: Healthy subjects:\n\n* Postmenopausal women aged 40 to 75 or men aged 40 to 75\n* No chronic disease or treatment\n* BMI \\\u003C30 kg\u002Fm², or\n* Fasting blood glucose \\\u003C 1.10 g\u002FdL\n\nGroup 2: metabolic syndrome patients\n\n* Postmenopausal women aged 40 to 75 or men aged 40 to 75\n* Metabolic syndrome as defined by the International Diabetes Federation (IDF 2006)5\n* BMI \\\u003C30 kg\u002Fm² and waist circumference \\>80 cm for women and \\>94 cm for men\n* Insulin resistance defined by HOMA-IR\\>2.4\n\nGroup 3: CKD dialysis patients\n\n* Non-diabetics\n* Postmenopausal women aged 40 to 75 and men aged 40 to 75\n* BMI \\\u003C30 kg\u002Fm².\n* Chronic kidney disease patients on dialysis - stable on HD for more than 3 months\n\nPatients and healthy subjects will be matched on age (+\u002F-3 years) and sex\n\nExclusion Criteria:\n\n* Non-stabilized pathology incompatible with physical exercise\n* Ongoing exercise retraining program\n* Nutritional supplementation in the 4 weeks preceding the study (antioxidants, vitamins, etc.)\n* Treatment influencing mitochondrial function (metformin, statin, etc.)\n* Failure to obtain written informed consent after a period of reflection\n* Subject not affiliated to a social security scheme, or not benefiting from such a scheme.\n* Person protected by law (under guardianship or curatorship)\n* Patient deprived of liberty\n* Diabetic patient\n* Family dyslipidemia\n* Participants who have reached the maximum amount of compensation for their participation in research projects\n* Person under psychiatric care\n* Person participating in another research project with an exclusion period still in progress.\n* Mentally handicapped, dementia, illiterate, language barrier with inability to understand study purpose and methodology",true,"ALL","40 Years","75 Years",{"count":98,"type":99},42,"ESTIMATED","INTERVENTIONAL",[102],"NA","This prospective, multicenter, cross-sectional, repeated-measures comparative study compared functional and biochemical response profiles to exercise between 2 groups of chronically ill patients (chronic renal failure dialysis patients and patients with metabolic syndrome) and a group of healthy subjects.\n\nThe hypothesis is that the addition of plasma metabolic intermediates associated with energy disorders linked to insulin resistance, will improve the sensitivity of the assessment of muscle oxidative metabolism abnormalities, as reported in exercise intolerant subjects.\n\nIn this way, the metabolomics approach during exercise would provide a biological and functional \"signature\" of insulin resistance of muscular origin, discriminating between insulin-resistant patients, healthy control subjects and dialysis patients, with an exercise metabolic profile approaching that observed in insulin-resistant patients. A better understanding of metabolic abnormalities could guide muscle rehabilitation.\n\nParticipants will be asked to perform an exercise test, with several blood samples taken at different exercise intensities.\n\nResearchers will compare the metabolic profile of three groups: patients with chronic kidney disease, patients with metabolic syndrome and healthy subjects:\n\n* V'O2-adjusted lactate at rest and during exercise\n* The combination of exercise energy metabolism intermediates reflecting insulin resistance among Krebs cycle cofactors\u002Fsubstrates, ß-oxidation cofactors\u002Fsubstrates, amino acids",[105,106],"Metabolic Syndrome","Dialysis; Complications",[108,109,110],"exercise test","Citric Acid Cycle","metabolomic","2024-11-22",{"date":113,"type":114},"2024-11-26","ACTUAL",{"date":116,"type":114},"2024-11-18",{"date":118,"type":99},"2026-11-18",{"name":5,"class":6},2]