[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xuxiang Zhang, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100570936","remote-ischemic-conditioning-for-non-proliferative-diabetic-retinopathy-100570936",false,"NCT06713720","Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy","Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy (RIC-NPDR)","RIC-NPDR","Inclusion Criteria:\n\n* Age between 40 and 80 years.\n* Diagnosed with Type 2 diabetes mellitus.\n* Diagnosed with mild to moderate non-proliferative diabetic retinopathy (NPDR) with a DR Severity Score (DRSS) grade of 20-47D.\n* Capable of performing daily activities independently.\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Presence of diabetic macular edema (macular thickness \\> 250 μm).\n* Significant eye diseases affecting evaluation, such as high myopia, severe cataract, corneal leucoma, glaucoma, retinal detachment, retinal vein occlusion, congenital eye diseases, ocular tumors, or severe infection.\n* History of ocular laser or intraocular surgery.\n* Poor imaging quality due to refractive media opacity.\n* Contraindication to fluorescein fundus angiography.\n* Unstable blood glucose (HbA1c ≥ 8.0%) despite oral antidiabetic drugs.\n* Severe diabetes complications within the past 6 months.\n* Severe, sustained hypertension (systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg).\n* Body mass index (BMI) ≥ 28 kg\u002Fm².\n* Hepatic or renal insufficiency: Alanine aminotransferase or aspartate aminotransferase \\> 2 times the upper limit of normal. Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73m². Urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg.\n* Myocardial infarction within the past 6 months.\n* Neurological diseases such as Alzheimer's, Parkinson's, cerebrovascular disease, intracranial tumor, cerebrovascular malformation, or aneurysm.\n* Contraindications to RIC, including one-sided subclavian artery stenosis, upper limb injuries or vascular diseases, or limb deformities.\n* Severe systemic diseases, such as malignant tumors with a life expectancy of less than 24 months.\n* Known pregnancy or breastfeeding.\n* Participation in other experimental clinical studies.\n* Any other conditions deemed unsuitable by the investigator.","ALL","40 Years","80 Years",{"count":21,"type":22},68,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to evaluate whether remote ischemic conditioning (RIC) is a safe and effective treatment for non-proliferative diabetic retinopathy (NPDR) in adults aged 40-80 years with type 2 diabetes. The study aims to address the limitations of current treatments for NPDR by using RIC, a technique involving repeated cycles of ischemia and hypoxia stimulation to activate protective mechanisms against retinal damage.\n\nThe main questions it aims to answer are:\n\nDoes RIC improve the Diabetic Retinopathy Severity Score (DRSS) after one year of treatment? Does RIC reduce the incidence of vision-threatening proliferative diabetic retinopathy (PDR)? What are the changes in retinal neurovascular unit parameters, visual acuity, and retinal oxygen saturation after RIC treatment?\n\nParticipants will:\n\nUndergo RIC therapy using a specialized device on both upper limbs (or a placebo intervention for the control group) for 1 year.\n\nComplete 5 cycles of RIC or placebo treatment twice daily, 5 days per week. Receive routine care for diabetic retinopathy as per clinical guidelines.\n\nKey outcome measures:\n\nPrimary outcome: Change in DRSS from baseline after one year. Secondary outcomes: Incidence of PDR, changes in visual acuity, retinal neurovascular unit measures, retinal oxygen saturation, and serum biomarkers (e.g., VEGF, CRP, IL-6).\n\nThis randomized, double-blind, placebo-controlled trial aims to recruit 68 participants to ensure 60 complete the study, accounting for a 13% dropout rate. The findings are expected to provide insights into RIC as a novel intervention for NPDR, reducing blindness risk and supporting future large-scale trials.",[28,29,30,31,32],"Diabetic Retinopathy","Non-Proliferative Diabetic Retinopathy","Remote Ischemic Conditioning","Diabetes Mellitus, Type 2","Randomized Controlled Trial",[29,28,34,30,32],"Retinal Neurovascular Unit","RECRUITING","2025-06-22",{"date":38,"type":39},"2025-06-26","ACTUAL",{"date":41,"type":39},"2025-04-20",{"date":43,"type":22},"2026-05-31",{"name":45,"class":46},"Xuxiang Zhang, MD","OTHER",2,""]