Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM | NCT07720479

NCT07720479

Overview

NCT ID: NCT07720479
Lead Sponsor: Weidong MiOTHER
Official Title: Intranasal Insulin for Prevention of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
Brief Summary: 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.
Conditions: Postoperative Delirium (POD)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Jul 1, 2026Estimated
Primary Completion Date: Feb 1, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Diagnosis of type 2 diabetes mellitus (T2DM) according to the World Health Organization (WHO) criteria.

Age ≥ 65 years.

Scheduled for elective hepatobiliary tumor resection with an anticipated surgical duration of ≥ 2 hours.

Voluntary provision of written informed consent by the patient or their legally authorized representative.

Exclusion Criteria:

Preoperative diagnosis of dementia, or an education-adjusted Mini-Mental State Examination (MMSE) score indicating cognitive impairment (illiteracy < 17, primary education < 20, secondary education or above < 24).

Severe visual, auditory, or language impairments precluding the completion of neurocognitive assessments.

American Society of Anesthesiologists (ASA) physical status classification ≥ IV.

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.

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).

Known hypersensitivity to insulin or any of its excipients.

Extremely poor glycemic control (e.g., HbA1c > 10%), or an episode of severe hypoglycemia or diabetic ketoacidosis within the 3 months prior to enrollment.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 210Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Danyang GengContact
1354550512@qq.com17367522284

Similar Studies

Participant Group/Arms

Intranasal Insulin 40 IU GroupExperimental

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.

Drug: Insulin, human

Intranasal Insulin 80 IU GroupExperimental

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.

Drug: Insulin, human

Control GroupPlacebo 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.

Drug: Intranasal Normal Saline (Placebo)