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Not yet recruiting NCT07369466

Association of Preoperative Hippocampal Glucose Metabolism With Postoperative Delirium in Older Diabetic Patients

Observational Postoperative Delirium Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Postoperative Delirium, Type 2 Diabetes. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Preoperative Hippocampal Glucose Metabolism Levels and the Risk of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Prospective Cohort Study

Overview

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.

Primary outcome measures

  • Incidence of Postoperative Delirium (POD) [Time frame: From surgery completion to postoperative day 7]
Secondary outcome measures (1)
  • Triglyceride-glucose (TyG) index [Time frame: Within 7 days before surgery (preoperative baseline)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • History of psychiatric disorders or current use of antipsychotic medications.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07369466 · PLAGH-PET-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗