Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM (NCT07720479) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM
210 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses intranasal insulin specifically for older patients with Type 2 diabetes who develop delirium after surgery — given my own diabetes management and upcoming procedure, is this trial even a realistic option worth keeping on my radar once it opens to recruitment?
2Since this trial is listed as 'not yet recruiting,' how long might it realistically be before enrollment opens, and should I be making treatment decisions now rather than waiting to see if I qualify?
3The trial is listed as Phase NA, which can sometimes mean it's an early feasibility or device study — what does that mean for how much is already known about the safety of giving insulin through a nasal spray right after surgery?
4If postoperative delirium does happen after my surgery, what are the standard approaches my care team would use right now, and how would participating in this trial change or delay access to those treatments?
5Are there specific types of surgery or levels of diabetes severity this trial is likely targeting, and based on my situation, is my doctor aware of any eligibility factors that might make this worth or not worth pursuing when it opens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Delirium
Timeframe: Postoperative Day 1 to Postoperative Day 7
. 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.