[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561961":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":56,"collaborators":32,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":32,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":32,"enrollmentInfo":69,"targetDuration":32,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Purdue University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SHAM","SHAM_COMPARATOR","In the sham group, water at 33ºC will be circulated through the leg sleeves.",[13],"Device: Sham",{"label":15,"type":16,"description":17,"interventionNames":18},"HEAT THERAPY","EXPERIMENTAL","In the leg heat therapy group, water at 42ºC will be circulated through the leg sleeves.",[19],"Device: Heat therapy",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Heat therapy","Participants will be provided with a heat therapy system comprising a controller unit with a water pump and air pump, a portable heater, and leg sleeves featuring inner-layer water-circulating pads and an outer layer of inflatable bladders. The system is engineered to facilitate effective heat transfer through gentle pneumatic inflation, accommodating various limb dimensions. The heater will be set to warm the water to 42°C. Participants will be instructed to administer the therapy for 90 minutes daily in a seated or supine position.",[15],[27],"Leg heating",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sham","Participants will be provided with a heat therapy system comprising a controller unit with a water pump and air pump, a portable heater, and leg sleeves featuring inner-layer water-circulating pads and an outer layer of inflatable bladders. The system is engineered to facilitate effective heat transfer through gentle pneumatic inflation, accommodating various limb dimensions. The heater will warm the water to 33°C. Participants will be instructed to administer the therapy for 90 minutes daily in a seated or supine position.",[9],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Bruno Tesini Roseguini, PhD","CONTACT","(765) 496-2612","brosegui@purdue.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","West Lafayette","Indiana","47907","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-86.90807,40.42587,{"lat":51,"lon":50},[54,55],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},{"name":35,"role":36,"phone":32,"phoneExt":32,"email":32},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Bruno Roseguini","Associate Professor","100561961","phase-1-heat-therapy-in-type-2-diabetes-100561961",false,"NCT06596967","Heat Therapy in Type 2 Diabetes","Home-based Heat Therapy in Older Adults with Type 2 Diabetes: a Pilot Trial","Inclusion Criteria:\n\n1. age 55 and older\n2. Type 2 Diabetes (documented by chart review, presence of treatment for type 2 Diabetes, fasting plasma glucose equal or greater than 126 mg\u002FdL or A1C equal or greater than 6.5%).\n\nExclusion Criteria:\n\n(1) HbA1c \\<6.5% or \\>9.0%, (2) body mass index \\> 40 kg\u002Fm2, (3) insulin-dependent Type 1 Diabetes Mellitus, (4) incident cardiovascular events in the last year (heart attack, stroke), (5) symptomatic coronary artery disease and\u002For heart failure, (6) uncontrolled hypertension (systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>110 mmHg), (7) hypotension (resting systolic BP \\< 90 mmHg), (8) use of walking aid other than a cane, (9) active cancer, (10) impaired thermal sensation in the legs, (11) unable to fit into water-circulating garments, (12) orthopedic complications that preclude completion of physical function tests, (13) contraindications or inability to undergo a DXA scan, including implants, devices, or other foreign material, and inability to attain correct position and\u002For remain motionless for the measurement.","ALL","55 Years",{"count":70,"type":71},24,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","This study aims to test whether home-based heat therapy (HT) can improve the health of older adults with type 2 diabetes (T2D). T2D is common in older adults and can lead to severe issues such as heart disease, disability, and early death. While regular exercise is known to help manage T2D, many people with the condition find it difficult to stay active. This study explores HT as a simple, non-invasive treatment that may offer similar benefits.\n\nParticipants will wear special leg sleeves that deliver heat to their legs for 90 minutes each day at home over 12 weeks. The study\\'s primary goal is to assess whether HT treatment at home is feasible and safe to use. We hypotesize that people with diabetes who receive heat therapy will have better blood sugar control, stronger legs, less body fat, and improved ability to walk, along with lower blood pressure.\n\nIf successful, HT could offer a new option for people with T2D to manage their condition, especially for those who struggle with regular exercise. This research could lead to larger studies and help provide a practical way to improve health and quality of life for older adults with diabetes.",[77],"Type 2 Diabetes",[79,80],"heat therapy","type 2 Diabetes","2024-09-11",{"date":83,"type":84},"2024-09-19","ACTUAL",{"date":86,"type":84},"2024-09-03",{"date":88,"type":71},"2025-07-31",{"name":5,"class":6},1]