[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566418":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":41,"locations":40,"responsibleParty":47,"collaborators":40,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":40,"enrollmentInfo":61,"targetDuration":40,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":40,"overallStatus":70,"whyStopped":40,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":40},{"fullName":5,"class":6},"Capital Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"RIC group","EXPERIMENTAL","Subjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment.",[13,14],"Device: Remote ischemic conditioning","Drug: Standard medication therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham group","SHAM_COMPARATOR","Subjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment.",[20,14],"Device: Sham remote ischemic conditioning",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Remote ischemic conditioning","RIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral arm. The procedure will be performed twice daily for consecutive 6 months after enrollment.",[9],[28],"RIC",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Sham remote ischemic conditioning","Sham RIC will be performed by the same electric auto-control device with cuff placed on arm. Sham RIC procedures consist of five cycles of 5-min inflation (60 mmHg) and 5-min deflation of cuff on bilateral arm. The procedure will be performed twice daily for consecutive 6 months after enrollment.",[16],[34],"Sham RIC",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Standard medication therapy","Standard medication therapy will be performed according to the national and international guidelines.",[9,16],null,[42],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Xunming Ji, MD, PhD","CONTACT","010-83199430","jixm@ccmu.edu.cn",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Ji Xunming,MD,PhD","professor","100566418","remote-ischemic-conditioning-for-the-treatment-of-diabetic-kidney-disease-100566418",false,"NCT06654921","Remote Ischemic Conditioning for the Treatment of Diabetic Kidney Disease","The Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Diabetic Kidney Disease: a Single-center Double-blinded Randomized Controlled Study","RIC-DKD","Inclusion Criteria:\n\n* History of type 2 diabetes and receiving at least 1 antidiabetic medication\n* CKD at stage G3 or G4 (eGFR = 15-60 mL\u002Fmin\u002F1.73 m2)\n* UACR ≥ 300 mg\u002Fg or urinary albumin excretion rate (UAER) ≥ 300 mg\u002F24 h\n* Patients are cognitively and physically capable and willing to interact with the device and perform self-measurements\n* Ability to withstand 5 full minutes of cuff inflation during prescreening\n\nExclusion Criteria:\n\n* Patients with New York Heart Association Class III or IV congestive heart failure at enrollment\n* Patients with severe illness with an expected lifespan of less than 6 months\n* Patients with a recent history (\\\u003C 6 months) of continuous renal replacement therapy, malignant tumor, myocardial infarction, acute coronary syndrome, stroke, seizure, thrombotic\u002Fthromboembolic event (e.g., deep vein thrombosis or pulmonary embolism), or a cerebrovascular accident\n* Patients with known severe arterial disease of the extremities (ulcers, amputations, known symptomatic peripheral arterial disease)\n* Patients at imminent risk of starting dialysis during the study period\n* Patients residing in a long-term care facility\n* Patients in another interventional trial that could influence the intervention or outcome of this trial","ALL","18 Years",{"count":62,"type":63},60,"ESTIMATED","INTERVENTIONAL",[66],"NA","Chronic kidney disease (CKD) is a growing epidemic affecting 10% of the population worldwide. Significantly, diabetic kidney disease (DKD) is the main cause of CKD and affects approximately 40% of patients with diabetes. Approximately 10% of patients with early-stage CKD and approximately half of patients with advanced-stage CKD suffer progression to renal failure and require dialysis or transplantation to survive. Moreover, DKD progresses particularly rapidly and has a poor prognosis, accounting for almost 50% of end-stage renal disease (ESRD) cases. Dialysis in particular is a burdensome therapy associated with poor patient outcomes and high societal and economic costs. Clinical studies using RIP have demonstrated protection against ischemic target renal damage in a variety of acute and chronic clinical settings . In the renal setting, RIP performed in dialysis patients is known to abrogate brain, heart and liver ischemia occurring during hemodialysis treatments. RIP may play a role in reducing the incidence of cardiac surgery-associated acute kidney injury. However, whether RIP can improve the renal function of patients with DKD is unclear and is worthy of further study.\n\nOur overarching hypothesis is that RIP, performed in DKD patients, could delay progression to renal failure by abrogating progressive ischemic damage in the failing kidney. The present proposal is a pilot study addressing this hypothesis and is aimed at generating proof-of-concept and feasibility data on the benefits of RIP in patients with DKD.",[69],"Diabetic Kidney Disease (DKD)","NOT_YET_RECRUITING","2024-10-21",{"date":73,"type":74},"2024-10-23","ACTUAL",{"date":76,"type":63},"2025-01",{"date":78,"type":63},"2025-12",{"name":5,"class":6}]