Postoperative Delirium (POD)NCT07720479
Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM
A study testing Insulin, human in people with Postoperative Delirium (POD), run by Weidong Mi.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium (POD)
- What is being tested?
- Insulin, human
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intranasal Insulin for Prevention of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
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)
- Being tested
- Insulin, human, Intranasal Normal Saline (Placebo)
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin, humanDrug
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
Intranasal Normal Saline (Placebo)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Insulin, human |
| Intranasal Insulin 80 IU Group | Experimental | 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. Receives: Drug: Insulin, human |
| 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. Receives: Drug: Intranasal Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium
The occurrence of postoperative delirium will be assessed using the 3D-CAM (3-Minute Diagnostic Interview for CAM). Assessments will be conducted twice daily (at 09:00-10:00 and 16:00-17:00) from postoperative day 1 through postoperative day 7.
Measured: Postoperative Day 1 to Postoperative Day 7
Secondary outcomes (2)
Postoperative Mild Cognitive Impairment (MCI)
Assessment of postoperative mild cognitive impairment (MCI) will be conducted using the Ascertain Dementia 8-item Informant Questionnaire (AD8). The AD8 is a brief screening tool rated by informants (caregivers or family members). A total score of ≥ 2 on the AD8 will indicate the presence of cognitive impairment.
Measured: Postoperative Day 7, 1 Month, and 6 Months
Postoperative Short-term Memory Impairment
Short-term memory will be assessed using the Three Words Delayed Recall Test (often referred to as TRT in this study). Patients are asked to recall three unrelated words previously presented. Failure to correctly recall all three words will be considered indicative of short-term memory impairment.
Measured: Postoperative Day 7, 1 Month, and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weidong Mi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720479
- Sponsor's protocol ID
- POD- INI- RCT2026
- Other IDs
- S2026-023-01
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including demographic data, intraoperative parameters, blood glucose levels, 3D-CAM scores, AD8 scores, and adverse events) will be shared. Data will be made available to researchers upon reasonable request after trial completion and approval by the corresponding author. A data use agreement may be required to ensure responsible use.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Insulin for Prevention of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
- ClinicalTrials.gov ID
- NCT07720479
- Acronym / sponsor ID
- POD- INI- RCT2026
- Conditions
- Postoperative Delirium (POD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Weidong MiUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intranasal Insulin 40 IU Group | Experimental | Drug: Insulin, humanSubjects 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. |
| Intranasal Insulin 80 IU Group | Experimental | Drug: Insulin, humanSubjects 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. |
| Control Group | Placebo comparator | Drug: Intranasal Normal Saline (Placebo)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin, humanSubjects 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 | Drug | Intranasal Insulin 40 IU Group, Intranasal Insulin 80 IU Group |
| 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. | Drug | Control Group |
Primary outcome
Postoperative Delirium
Time frame: Postoperative Day 1 to Postoperative Day 7
The occurrence of postoperative delirium will be assessed using the 3D-CAM (3-Minute Diagnostic Interview for CAM). Assessments will be conducted twice daily (at 09:00-10:00 and 16:00-17:00) from postoperative day 1 through postoperative day 7.
2 secondary outcomes
Postoperative Mild Cognitive Impairment (MCI)
Time frame: Postoperative Day 7, 1 Month, and 6 Months
Postoperative Short-term Memory Impairment
Time frame: Postoperative Day 7, 1 Month, and 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including demographic data, intraoperative parameters, blood glucose levels, 3D-CAM scores, AD8 scores, and adverse events) will be shared. Data will be made available to researchers upon reasonable request after trial completion and approval by the corresponding author. A data use agreement may be required to ensure responsible use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin, human in people with Postoperative Delirium (POD), run by Weidong Mi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danyang Geng (17367522284, 1354550512@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium (time frame: Postoperative Day 1 to Postoperative Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.