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Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM

21. juli 2026 opdateret af: Weidong Mi

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

210

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intranasal Insulin 40 IU Group
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.
Medicin: Insulin, human
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
Eksperimentel: Intranasal Insulin 80 IU Group
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.
Medicin: Insulin, human
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
Placebo komparator: Control Group
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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Delirium
Tidsramme: 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.
Postoperative Day 1 to Postoperative Day 7

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Mild Cognitive Impairment (MCI)
Tidsramme: Postoperative Day 7, 1 Month, and 6 Months
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.
Postoperative Day 7, 1 Month, and 6 Months
Postoperative Short-term Memory Impairment
Tidsramme: Postoperative Day 7, 1 Month, and 6 Months
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.
Postoperative Day 7, 1 Month, and 6 Months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Postoperative Adverse Events
Tidsramme: Within 30 days after surgery
Incidence of adverse events within 30 days after surgery, including cardiovascular events, ischemic stroke, pulmonary infection, and acute kidney injury.
Within 30 days after surgery
Postoperative Pain Severity (NRS 0-10)
Tidsramme: Daily for the first 7 days after surgery
Postoperative pain severity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates "no pain" and 10 represents "the worst imaginable pain".
Daily for the first 7 days after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Weidong Mi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. februar 2028

Studieafslutning (Anslået)

1. februar 2028

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • POD- INI- RCT2026
  • S2026-023-01 (Anden identifikator: Ethics Committee of the Chinese PLA General Hospital)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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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Kliniske forsøg med Postoperativt delirium (POD)

Kliniske forsøg med Insulin, human

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