[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572536":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":71,"studyPopulation":71,"armGroups":80,"interventions":95,"overallOfficials":100,"centralContacts":106,"locations":116,"responsibleParty":146,"collaborators":149,"id":156,"slug":71,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":157,"sex":163,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":71,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":118,"whyStopped":71,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"Hasselt University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":71},[9,13],{"measure":10,"description":11,"timeFrame":12},"Neurometabolite levels","Levels of N-acetylaspartate, choline, myo-inositol, creatine, glutathion, and glutamate, measured in institutional units (i.u.) by means of magnetic resonance spectroscopy (MRS).","From enrollment to the end of treatment at 6 months",{"measure":14,"description":15,"timeFrame":12},"Changes in arterial spin labelling measured by means of magnetic resonance imaging (MRI)","Changes in cerebral perfusion expressed in mL\u002F100g\u002Fmin, and blood flow through the blood-brain-barrier expressed in milliseconds",[17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68],{"measure":18,"description":19,"timeFrame":12},"Levels of neurodegenerative blood biomarkers","Tau (pg\u002FmL), amyloid beta (pg\u002FmL), S100B (ng\u002FmL), neurofilament light (pg\u002FmL) etc.",{"measure":21,"description":22,"timeFrame":12},"Blood lipid profile","This outcome measure includes assessments of the lipid profile, reported in milligrams per deciliter (mg\u002FdL) or millimoles per liter (mmol\u002FL):\n\nHigh-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), Triglycerides, Free Fatty Acids, Total Cholesterol",{"measure":24,"description":25,"timeFrame":12},"Brain volume","Total and regional (LHIPP, mPFC, PCC) brain volumes",{"measure":27,"description":28,"timeFrame":12},"Diffusion-weighted magnetic resonance imaging","DWI will be used to measure differences in Brownian motion of water molecules within the brain",{"measure":30,"description":31,"timeFrame":12},"Fasted blood glucose","Fasting Glucose: Reported in milligrams per deciliter (mg\u002FdL) or millimoles per liter (mmol\u002FL).",{"measure":33,"description":34,"timeFrame":12},"Kidney function (eGFR)","Estimated Glomerular Filtration Rate (eGFR): Reported in milliliters per minute per 1.73 m² (mL\u002Fmin\u002F1.73 m²).",{"measure":36,"description":37,"timeFrame":12},"Cognitive function: MoCA","Cognitive function as assessed by the Montreal Cognitive Assessment (MoCA), scored on a scale of 0-30.",{"measure":39,"description":40,"timeFrame":12},"Cognitive function: Face recognition test","Cognitive function as assessed by the Face Recognition Test, reported as the number of correct identifications.",{"measure":42,"description":43,"timeFrame":12},"Cognitive function: Object location test","Cognitive function as assessed by the Object Location Test, reported as the number of correct placements.",{"measure":45,"description":46,"timeFrame":12},"Cognitive function: Trail making test","Cognitive function as assessed by the Trail Making Test, reported as time to completion (seconds) for Parts A and B.",{"measure":48,"description":49,"timeFrame":12},"Cognitive function: Stroop colour and word test","Cognitive function as assessed by the Stroop Color and Word Test, reported as time to completion (seconds) or number of errors.",{"measure":51,"description":52,"timeFrame":12},"Cognitive function: Rey auditory verbal learning test","Cognitive function as assessed by the Rey Auditory Verbal Learning Test, reported as the number of words recalled.",{"measure":54,"description":55,"timeFrame":12},"Subjective cognitive function","Cognitive function as assessed by the Cognitive Failure Questionnaire, scored on a scale of 0-100.",{"measure":57,"description":58,"timeFrame":12},"Peak load during CPET","The maximum load achieved during cardiopulmonary exercise testing (CPET) on a bicycle, measured in watts.",{"measure":60,"description":61,"timeFrame":12},"VO2peak during CPET","The peak oxygen consumption measured during CPET, indicating the maximal capacity for oxygen utilization during exercise.\n\nUnit of Measure: Milliliters per kilogram per minute (mL\u002Fkg\u002Fmin).",{"measure":63,"description":64,"timeFrame":12},"Fasted blood HbA1c","Hemoglobin A1c (HbA1c): Reported as a percentage (%).",{"measure":66,"description":67,"timeFrame":12},"Fasting insulin","Fasting Insulin: Reported in micro-international units per milliliter (μIU\u002FmL) or picomoles per liter (pmol\u002FL).",{"measure":69,"description":70,"timeFrame":12},"Kidney function (creatinine)","Creatinine: Reported in milligrams per deciliter (mg\u002FdL) or micromoles per liter (μmol\u002FL).",null,{"allocation":73,"interventionModel":74,"interventionModelDescription":71,"primaryPurpose":75,"observationalModel":71,"timePerspective":71,"maskingInfo":76},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":77,"maskingDescription":71,"whoMasked":78},"SINGLE",[79],"OUTCOMES_ASSESSOR",[81,87,91],{"label":82,"type":83,"description":84,"interventionNames":85},"High intensity exercise training group","EXPERIMENTAL","This arm will receive 6 months of exercise training at high intensity (105% VT2)",[86],"Other: Exercise intervention",{"label":88,"type":83,"description":89,"interventionNames":90},"Moderate intensity exercise training group","This arm will receive 6 months of exercise training at moderate intensity (60% VT2)",[86],{"label":92,"type":93,"description":94,"interventionNames":71},"Control group","NO_INTERVENTION","This arm won't receive exercise training",[96],{"type":6,"name":97,"description":98,"armGroupLabels":99,"otherNames":71},"Exercise intervention","The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week",[82,88],[101,104],{"name":102,"affiliation":5,"role":103},"Dominique Hansen, Full professor","PRINCIPAL_INVESTIGATOR",{"name":105,"affiliation":5,"role":103},"Koen Cuypers, Assistant professor",[107,112],{"name":108,"role":109,"phone":110,"phoneExt":71,"email":111},"Dominique Hansen, Full Professor","CONTACT","+3211292126","dominique.hansen@uhasselt.be",{"name":113,"role":109,"phone":114,"phoneExt":71,"email":115},"Jitske Vandersmissen, PhD student","+3211268387","jitske.vandersmissen@uhasselt.be",[117],{"facility":5,"status":118,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":130},"RECRUITING","Hasselt","Limburg","3500","Belgium","BE",{"type":125,"coordinates":126},"Point",[127,128],5.33781,50.93106,{"lat":128,"lon":127},[131,132,135,137,139,141,143,144],{"name":102,"role":109,"phone":110,"phoneExt":71,"email":111},{"name":105,"role":109,"phone":133,"phoneExt":71,"email":134},"+3211269316","koen.cuypers@uhasselt.be",{"name":113,"role":136,"phone":71,"phoneExt":71,"email":71},"SUB_INVESTIGATOR",{"name":138,"role":136,"phone":71,"phoneExt":71,"email":71},"Robin Heemels, PhD student",{"name":140,"role":136,"phone":71,"phoneExt":71,"email":71},"Melina Hehl, PhD",{"name":142,"role":136,"phone":71,"phoneExt":71,"email":71},"Ilse Dewachter, Full professor",{"name":105,"role":103,"phone":71,"phoneExt":71,"email":71},{"name":145,"role":136,"phone":71,"phoneExt":71,"email":71},"Stefan Sunaert, Professor",{"type":103,"investigatorFullName":147,"investigatorTitle":148,"investigatorAffiliation":5,"oldNameTitle":71,"oldOrganization":71},"Dominique Hansen","Full professor",[150,152,154],{"name":151,"class":6},"Universitaire Ziekenhuizen KU Leuven",{"name":153,"class":6},"Jessa Hospital",{"name":155,"class":6},"Research Foundation Flanders","100572536",false,"NCT06734546","The Effect of Exercise on the Brain in Type 2 Diabetes","The Effect of Exercise of High vs. Moderate Intensity on the Brain in Type 2 Diabetes","SAINT","Inclusion Criteria:\n\n* type 2 diabetes\n* no insulin therapy\n* 30-75 years old\n* physically inactive\n\nExclusion Criteria:\n\n* MRI contraindications\n* psychological disorders\n* exogenous insulin therapy\n* history of coma, transient ischemic attack, head trauma, brain tumor, stroke, epilepsy, and other central nervous system diseases that could cause dementia or presence of dementia before T2DM\n* suffering from any disease with significant impact on exercise intervention participation such as: chronic heart disease (e.g. valve insufficiency ≥ grade 2) or significant arrhythmias, cardiac events less than one year ago (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), clinical heart failure (oedema, shortness of breath), percutaneous coronary intervention less than one year ago, chronic obstructive pulmonary disease (COPD), cerebrovascular or peripheral vascular disease\n* severe hypertension (\\>160\u002F110 mmHg)\n* ongoing cancer, severe neuropathy (limiting exercise participation)\n* renal disease (GRF \\\u003C45 ml\u002Fmin\u002F1,73 m2)\n* inability to regularly participate in the exercise intervention\n* pregnancy\n* breastfeeding","ALL","30 Years","75 Years",{"count":167,"type":168},75,"ESTIMATED","INTERVENTIONAL",[171],"NA","The goal of this clinical trial is to learn if exercise training of high or moderate intensity is most optimal to improve brain health and prevent neurodegeneration in type 2 diabetes patients. The main question it aims to answer is:\n\nWhat is the effect of exercise training of high vs. moderate intensity on brain metabolism, brain perfusion, and cognition in type 2 diabetes?\n\nResearchers will compare the exercise training groups to a control group without exercise training to determine the effect of exercise training on the brain in type 2 diabetes.\n\nParticipants will exercise for 6 months, 3 times per week. Before and after these 6 months, they will undergo:\n\n* a brain MRI scan\n* cognitive tests\n* blood sampling",[174],"Type 2 Diabetes",[176,177,178,179,180,181,182],"type 2 diabetes","exercise intervention","brain","cognition","neurometabolism","dementia","cerebral perfusion","2026-03-30",{"date":185,"type":186},"2026-03-31","ACTUAL",{"date":188,"type":186},"2024-11-08",{"date":190,"type":168},"2027-08",{"name":5,"class":6},1]