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

NCT06426953 | Recruiting

• 1 other identifier: IRB-2024-467（IIT）
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Diabetes; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

History of diabetes ≥2 years and Glycated hemoglobin ≥6.5%

Diabetic patients with a history of more than 2 years

Other: No intervention

No history of diabetes and normal blood glucose

Patients without a history of diabetes

Other: No intervention

Interventions

No intervention OTHER

No intervention

History of diabetes ≥2 years and Glycated hemoglobin ≥6.5%; No history of diabetes and normal blood glucose

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xie Kangjie: lead

Study Sites (2)

The People's hospital of Qiannan

Duyun, Guizhou, 558000, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A total of 3 mL peripheral blood samples were collected within 30 minutes before surgery and placed in a coagulation test tube at 4 °C. After centrifugation at 3000 rpm for 10 minutes at 4 °C, the plasma was separated, transferred into cryopreservation tubes, and stored at -80 °C. Upon collecting a sufficient number of samples, TGF-β, ADNP, MAP6, and PGC-1α were detected in the laboratory

MeSH Terms

Conditions

Diabetes Mellitus; Emergence Delirium

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kangjie Xie, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kangjie Xie, MD

CONTACT

8613516721870; xiekj@zjcc.org.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: May 20, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: September 29, 2025

Record last verified: 2024-12

Locations

CN (2)