NCT07720479Not yet recruiting
Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM
Intranasal Insulin for Prevention of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Weidong Mi
- Diseases
- Type 2 diabetes
- NCT number
- NCT07720479
What you commit to
- Study type: Interventional
- Planned participants: 210
- From 1 Jul 2026 to the primary completion date, 1 Feb 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
- 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.
Lab values
- Extremely poor glycemic control (e.g., HbA1c \> 10%), or an episode of severe hypoglycemia or diabetic ketoacidosis within the 3 months prior to enrollment.
Other
- Severe visual, auditory, or language impairments precluding the completion of neurocognitive assessments.
- American Society of Anesthesiologists (ASA) physical status classification ≥ IV.
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.