About this trial
Objective: To investigate the association between preoperative hippocampal glucose metabolism levels and the risk of postoperative delirium (POD) in elderly patients with type 2 diabetes (T2DM), and to provide a prospective neuroimaging biomarker for identifying high-risk populations.
Methods: This prospective cohort study plans to enroll 154 elderly T2DM patients scheduled for liver tumor resection at the First Medical Center of Chinese PLA General Hospital. Baseline cognitive function will be assessed using the Mini-Mental State Examination (MMSE) one day before surgery. Hippocampal glucose metabolism will be quantitatively evaluated by measuring the mean standardized uptake value (SUVmean) of bilateral hippocampi using ¹⁸F-FDG PET/CT. POD will be assessed twice daily from postoperative days 1 to 7 using the 3-Minute Diagnostic Interview for CAM (3D-CAM). The correlation between preoperative hippocampal SUVmean and POD incidence will be analyzed using univariate and multivariate logistic regression models. The predictive performance will be evaluated by constructing receiver operating characteristic (ROC) curves. Furthermore, the relationship between a peripheral insulin resistance marker (the triglyceride-glucose index, TyG index) and hippocampal metabolism levels will be analyzed.
Significance: This study aims to determine whether impaired preoperative hippocampal metabolism serves as an independent risk factor for POD. The findings are expected to provide a prospective functional neuroimaging biomarker for the early warning of POD and offer a theoretical basis for developing precise prevention strategies targeting cerebral metabolic abnormalities. This will facilitate the application of neuroimaging techniques in the field of perioperative brain dysfunction monitoring.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with type 2 diabetes mellitus (T2DM).
Age ≥ 65 years.
Scheduled for elective liver tumor resection surgery with an expected operative duration > 2 hours.
Underwent whole-body ¹⁸F-FDG PET/CT scan within 1 month prior to surgery.
Disqualifiers
Patient declines to participate.
Inability to cooperate with cognitive assessments or a preoperative Mini-Mental State Examination (MMSE) score < 23.
American Society of Anesthesiologists (ASA) physical status classification ≥ IV.
History of organic brain disorders, including stroke, traumatic brain injury, or intracranial tumors.
Trial population
This prospective cohort study will enroll elderly patients (age ≥ 65 years) diagnosed with type 2 diabetes mellitus (T2DM) who are scheduled for elective liver tumor resection surgery with an expected duration of \>2 hours at the First Medical Center of Chinese PLA General Hospital. All participants will undergo preoperative ¹⁸F-FDG PET/CT scanning and cognitive assessment, and will be prospectively followed for the occurrence of postoperative delirium.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of Postoperative Delirium (POD)
Assessed by the 3-Minute Diagnostic Interview for CAM (3D-CAM), administered twice daily.
Secondary outcomes
Triglyceride-glucose (TyG) index
Calculated as Ln \[fasting triglycerides (mg/dL) × fasting glucose (mg/dL) / 2\].
Other outcomes
Incidence of Postoperative Adverse Events within 30 Days
Incidence of postoperative adverse events within 30 days, including but not limited to cardiovascular adverse events, ischemic stroke, pulmonary infection, acute kidney injury, and pain assessment.
Locations
Sponsors and contacts
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