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NCT Number: NCT06426953

Predictive Effect of TGF-β and INS-PI3K-AKT Related Proteins 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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

No intervention

Other

No intervention

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.

    Time frame: 2024-05 to 2026-06

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kangjie Xie, MD

CONTACT

[email protected]

8613516721870

Sponsors and collaborators

Lead sponsor

Xie Kangjie

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 23, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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