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Can a nasal spray of insulin shield the aging brain from Post-Surgery confusion?

NCT ID NCT07720479

Prevention Sponsor: Weidong Mi Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial investigates whether a nasal spray containing insulin can prevent postoperative delirium—a sudden, temporary state of confusion—in older adults (65+) with type 2 diabetes who are undergoing liver tumor surgery. Participants are randomly assigned to receive one of two doses of intranasal insulin or a placebo spray before and after surgery. The study aims to see if improving the brain's response to insulin can reduce the risk of delirium and early cognitive decline.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intranasal insulin (human insulin given as a nasal spray)
What this could lead to
If it works, this could offer a simple, non-invasive way to prevent postoperative delirium in older adults with diabetes.
What could go wrong
This is an early-stage trial with a small sample size. The optimal dose is unknown, and intranasal insulin may cause nasal irritation or hypoglycemia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of type 2 diabetes mellitus (T2DM) according to the World Health Organization (WHO) criteria. 2. Age ≥ 65 years. 3. Scheduled for elective hepatobiliary tumor resection with an anticipated surgical duration of ≥ 2 hours. 4. Voluntary provision of written informed consent by the patient or their legally authorized representative. Exclusion Criteria: 1. 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). 2. Severe visual, auditory, or language impairments precluding the completion of neurocognitive assessments. 3. American Society of Anesthesiologists (ASA) physical status classification ≥ IV. 4. 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. 5. 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). 6. Known hypersensitivity to insulin or any of its excipients. 7. Extremely poor glycemic control (e.g., HbA1c \> 10%), or an episode of severe hypoglycemia or diabetic ketoacidosis within the 3 months prior to enrollment.

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Conditions

The condition(s) this trial relates to.

Emergence Delirium type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postoperative delirium (POD)

How to take part

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  1. The official record

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