Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:28 AM
Study NCT ID:
NCT07369466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Preoperative Hippocampal Glucose Metabolism With Postoperative Delirium in Older Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2026-01-10', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Postoperative Adverse Events within 30 Days', 'timeFrame': 'From surgery completion to postoperative day 30', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Incidence of Postoperative Delirium (POD)', 'timeFrame': 'From surgery completion to postoperative day 7', 'description': 'Assessed by the 3-Minute Diagnostic Interview for CAM (3D-CAM), administered twice daily.'}], 'secondaryOutcomes': [{'measure': 'Triglyceride-glucose (TyG) index', 'timeFrame': 'Within 7 days before surgery (preoperative baseline)', 'description': 'Calculated as Ln \\[fasting triglycerides (mg/dL) × fasting glucose (mg/dL) / 2\\].'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative delirium', 'Type 2 Diabetes Mellitus', 'Positron-Emission Tomography', 'Hippocampus', 'Glucose metabolism'], 'conditions': ['Postoperative Delirium', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': '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.\n\nMethods: 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.\n\nSignificance: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with type 2 diabetes mellitus (T2DM).\n2. Age ≥ 65 years.\n3. Scheduled for elective liver tumor resection surgery with an expected operative duration \\> 2 hours.\n4. Underwent whole-body ¹⁸F-FDG PET/CT scan within 1 month prior to surgery.\n\nExclusion Criteria:\n\n1. Patient declines to participate.\n2. Inability to cooperate with cognitive assessments or a preoperative Mini-Mental State Examination (MMSE) score \\< 23.\n3. American Society of Anesthesiologists (ASA) physical status classification ≥ IV.\n4. History of organic brain disorders, including stroke, traumatic brain injury, or intracranial tumors.\n5. History of psychiatric disorders or current use of antipsychotic medications.'}, 'identificationModule': {'nctId': 'NCT07369466', 'briefTitle': 'Association of Preoperative Hippocampal Glucose Metabolism With Postoperative Delirium in Older Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Preoperative Hippocampal Glucose Metabolism Levels and the Risk of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'PLAGH-PET-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Older T2DM Hepatectomy Cohort'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Weidong Mi, Professor', 'role': 'CONTACT', 'email': 'wwdd1962@163.com', 'phone': '86+13381082966'}, {'name': 'Danyang Geng, Master', 'role': 'CONTACT', 'email': 'sphm123@126.com', 'phone': '86+17367522284'}], 'overallOfficials': [{'name': 'Weidong Mi, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Medical Center of Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'A data sharing plan has not been fully formulated yet and will be finalized prior to the completion of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Weidong Mi', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}