[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648305":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":35,"locations":30,"responsibleParty":41,"collaborators":30,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":30,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":30,"enrollmentInfo":54,"targetDuration":30,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":30,"overallStatus":63,"whyStopped":30,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":30},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal Insulin 40 IU Group","EXPERIMENTAL","Subjects will receive intranasal insulin treatment at a dose of 20 IU twice daily (totaling 40 IU per day), administered 15 minutes prior to anesthesia induction and continued from postoperative day 1 through postoperative day 7. The scheduled administration time windows are 09:00-10:00 and 16:00-17:00.",[13],"Drug: Insulin, human",{"label":15,"type":10,"description":16,"interventionNames":17},"Intranasal Insulin 80 IU Group","Subjects will receive intranasal insulin treatment at a dose of 40 IU twice daily (totaling 80 IU per day), administered 15 minutes prior to anesthesia induction and continued from postoperative day 1 through postoperative day 7. The scheduled administration time windows are 09:00-10:00 and 16:00-17:00.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Control Group","PLACEBO_COMPARATOR","Subjects will receive intranasal treatment with volume-matched normal saline (20 IU equivalent per spray) twice daily (totaling 80 IU equivalent per day). Administration will occur 15 minutes prior to anesthesia induction and continue from postoperative day 1 through postoperative day 7, during the time windows of 09:00-10:00 and 16:00-17:00.",[23],"Drug: Intranasal Normal Saline (Placebo)",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Insulin, human","Subjects will receive intranasal insulin treatment. The specific dosage will vary by study arm: Group 1 receives 40 IU daily (20 IU twice daily), Group 2 receives 80 IU daily (40 IU twice daily), and the control group receives intranasal placebo. Administration occurs 15 minutes prior to anesthesia induction and continues daily from postoperative day 1 through postoperative day 7.Intranasal insulin",[9,15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Intranasal Normal Saline (Placebo)","0.9% sodium chloride solution for intranasal administration, matched in volume and appearance to the insulin preparation. Administered via the same nasal spray device twice daily (equivalent volume to the 80 IU insulin arm) beginning 15 min before anesthesia induction and continuing postoperatively until POD 7.",[19],[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Danyang Geng","CONTACT","17367522284","1354550512@qq.com",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Weidong Mi","Professor and Chairman, Department of Anesthesiology","100648305","intranasal-insulin-for-postoperative-delirium-in-older-patients-with-t2dm-100648305",false,"NCT07720479","Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM","Intranasal Insulin for Prevention of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial","Inclusion Criteria:\n\n1. Diagnosis of type 2 diabetes mellitus (T2DM) according to the World Health Organization (WHO) criteria.\n2. Age ≥ 65 years.\n3. Scheduled for elective hepatobiliary tumor resection with an anticipated surgical duration of ≥ 2 hours.\n4. Voluntary provision of written informed consent by the patient or their legally authorized representative.\n\nExclusion Criteria:\n\n1. Preoperative diagnosis of dementia, or an education-adjusted Mini-Mental State Examination (MMSE) score indicating cognitive impairment (illiteracy \\\u003C 17, primary education \\\u003C 20, secondary education or above \\\u003C 24).\n2. Severe visual, auditory, or language impairments precluding the completion of neurocognitive assessments.\n3. American Society of Anesthesiologists (ASA) physical status classification ≥ IV.\n4. History of severe central nervous system disorders (e.g., Parkinson's disease, stroke within the past 6 months, severe traumatic brain injury) or schizophrenia; or chronic use of antipsychotic or antidepressant medications.\n5. Nasal anatomical abnormalities or pathologies that may compromise intranasal drug absorption (e.g., severe allergic rhinitis, severe deviated septum, recent nasal trauma or surgery, nasal polyps).\n6. Known hypersensitivity to insulin or any of its excipients.\n7. Extremely poor glycemic control (e.g., HbA1c \\> 10%), or an episode of severe hypoglycemia or diabetic ketoacidosis within the 3 months prior to enrollment.","ALL","65 Years",{"count":55,"type":56},210,"ESTIMATED","INTERVENTIONAL",[59],"NA","Postoperative delirium (POD) is highly prevalent in older patients with type 2 diabetes mellitus (T2DM). Cerebral insulin resistance is considered a key pathophysiological mechanism underlying this association. This study aims to investigate whether intranasal insulin (INI) can prevent POD and early postoperative cognitive decline by improving cerebral insulin resistance. We will conduct a randomized, double-blind, placebo-controlled multicenter trial. Older T2DM patients will be randomly assigned to receive intranasal insulin at doses of 40 IU or 80 IU, or placebo. The primary objective is to evaluate the efficacy of INI in preventing POD and to determine the dose-response relationship.",[62],"Postoperative Delirium (POD)","NOT_YET_RECRUITING","2026-07-21",{"date":66,"type":67},"2026-07-22","ACTUAL",{"date":69,"type":56},"2026-07-01",{"date":71,"type":56},"2028-02-01",{"name":43,"class":6}]