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Recruiting NCT06426953

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

Observational Diabetes Postoperative Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Diabetes, Postoperative Delirium. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 2 centers
  • The People's hospital of Qiannan — Duyun
  • Zhejiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT06426953 · IRB-2024-467(IIT)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗