Postoperative DeliriumNCT07369466
Association of Preoperative Hippocampal Glucose Metabolism With Postoperative Delirium in Older Diabetic Patients
An observational study of Postoperative Delirium and Type 2 Diabetes, run by Chinese PLA General Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Type 2 Diabetes
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Postoperative Delirium, Type 2 Diabetes
- Keywords
- Postoperative delirium, Type 2 Diabetes Mellitus, Positron-Emission Tomography, Hippocampus, Glucose metabolism
- Medical subject headings
- Emergence Delirium, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older T2DM Hepatectomy Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium (POD)
Assessed by the 3-Minute Diagnostic Interview for CAM (3D-CAM), administered twice daily.
Measured: From surgery completion to postoperative day 7
Secondary outcomes (1)
Triglyceride-glucose (TyG) index
Calculated as Ln [fasting triglycerides (mg/dL) × fasting glucose (mg/dL) / 2].
Measured: Within 7 days before surgery (preoperative baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Weidong Mi, Professor, Study chair, The First Medical Center of Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369466
- Sponsor's protocol ID
- PLAGH-PET-01
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A data sharing plan has not been fully formulated yet and will be finalized prior to the completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Hippocampal Glucose Metabolism Levels and the Risk of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07369466
- Acronym / sponsor ID
- PLAGH-PET-01
- Conditions
- Postoperative Delirium, Type 2 Diabetes
- Keywords
- Postoperative delirium, Type 2 Diabetes Mellitus, Positron-Emission Tomography, Hippocampus, Glucose metabolism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older T2DM Hepatectomy Cohort | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Triglyceride-glucose (TyG) index
Time frame: Within 7 days before surgery (preoperative baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided. A data sharing plan has not been fully formulated yet and will be finalized prior to the completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weidong Mi, Professor study chair
The First Medical Center of Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Type 2 Diabetes, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weidong Mi, Professor (86+13381082966, wwdd1962@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (POD) (time frame: From surgery completion to postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.