- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369466
Association of Preoperative Hippocampal Glucose Metabolism With Postoperative Delirium in Older Diabetic Patients
Preoperative Hippocampal Glucose Metabolism Levels and the Risk of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Prospective Cohort Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Weidong Mi, Professor
- Phone Number: 86+13381082966
- Email: wwdd1962@163.com
Study Contact Backup
- Name: Danyang Geng, Master
- Phone Number: 86+17367522284
- Email: sphm123@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Older T2DM Hepatectomy Cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Postoperative Delirium (POD)
Time Frame: From surgery completion to postoperative day 7
|
Assessed by the 3-Minute Diagnostic Interview for CAM (3D-CAM), administered twice daily.
|
From surgery completion to postoperative day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Triglyceride-glucose (TyG) index
Time Frame: Within 7 days before surgery (preoperative baseline)
|
Calculated as Ln [fasting triglycerides (mg/dL) × fasting glucose (mg/dL) / 2].
|
Within 7 days before surgery (preoperative baseline)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Postoperative Adverse Events within 30 Days
Time Frame: From surgery completion to postoperative day 30
|
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.
|
From surgery completion to postoperative day 30
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Weidong Mi, Professor, The First Medical Center of Chinese PLA General Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Endocrine System Diseases
- Nervous System Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Metabolic Diseases
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Delirium
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Emergence Delirium
- Diabetes Mellitus, Type 2
Other Study ID Numbers
- PLAGH-PET-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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