Predictive Effect of TGF-β and INS-PI3K-AKT Related Proteins for POD in Diabetes Patients

Predictive Effect of TGF-β Combined With INS-PI3K-AKT Signaling Pathway Related Proteins (ADNP, MAP6, Pgc-1α) for POD in Diabetes Patients

To investigate the relationship between POD, TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) in diabetic patients

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Postoperative Delirium
• Intervention / Treatment: Other: No intervention

Detailed Description

The study was a two-center, prospective，single blind (blinded to subjects and evaluators)，control, observational clinical study. Participants will collect 3 milliliters of blood from enrolled patients before surgery begins. The collected blood samples were processed and stored in -80℃ refrigerator. All samples were tested TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) by ELISA.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Kangjie Xie, MD; Phone Number: 8613516721870; Email: xiekj@zjcc.org.cn

Study Locations

• China
  • Guizhou
    • Duyun, Guizhou, China, 558000
      • Not yet recruiting
      • The People's Hospital Of QianNan
      • Contact: Kai He, MD
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Kangjie Xie, MD; Phone Number: 008613516721870; Email: xiekj@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Elderly patients with a history of diabetes ≥2 years and a glycated hemoglobin of ≥6.5% or without a history of diabetes and a normal blood glucose level

Description

Inclusion Criteria:

1. Age ≥65 years
2. History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% or no history of diabetes and normal blood glucose
3. The ASA rating is Class I to III
4. The elderly patients of limited thoracic and abdominal tumor surgery

Exclusion Criteria:

1. Refused to participate
2. Previous history of schizophrenia, epilepsy, Parkinson's disease
3. History of alcohol abuse or drug dependence
4. Patients with ASA grade IV and above
5. Severe visual or hearing impairment, can not cooperate with the completion of cognitive function tests
6. Participants in other clinical trials within the last two months
7. Patients with severe arrhythmia or cardiac dysfunction(EF<40%)
8. There was a clear history of neurological and psychiatric problems or long-term use of sedatives or antidepressants
9. History of cerebrovascular disease or brain surgery or trauma
10. Severe liver dysfunction (Child-Pugh class C) or severe renal dysfunction (requiring dialysis)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
History of diabetes ≥2 years and Glycated hemoglobin ≥6.5%; Diabetic patients with a history of more than 2 years	Other: No intervention; No intervention
No history of diabetes and normal blood glucose; Patients without a history of diabetes	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation between preoperative plasma levels of TGF-β, ADNP, MAP6, PGC-1α and the incidence of delirium within 3 days after operation was analyzed.	Postoperative delirium (POD) was assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM). Transforming growth factor-beta (TGF-β), activity-dependent neuroprotective protein (ADNP), microtubule-associated protein 6 (MAP6), and peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) levels were measured using enzyme-linked immunosorbent assay (ELISA) kits.	2024-05 to 2026-06

Collaborators and Investigators

• Sponsor: Xie Kangjie
• Investigators: Principal Investigator: Kangjie Xie, MD, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: May 19, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• 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; Delirium; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Emergence Delirium; Diabetes Mellitus
• Other Study ID Numbers: IRB-2024-467（IIT）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No