Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM

Starting soon · Not applicable · Has a placebo group

Conditions studied: Postoperative Delirium (POD)

In brief

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.

Key facts

Study ID

NCT07720479

Run by

Weidong Mi

People needed

210

Starts

2026-07-01

Expected to finish

2028-02-01

Last updated by the study team

2026-07-22

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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