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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06426953
Enrollment
180
Registered
2024-05-23
Start date
2024-05-20
Completion date
2026-08-30
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Postoperative Delirium

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

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

OTHERNo intervention

No intervention

Sponsors

Xie Kangjie
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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.2024-05 to 2026-06Postoperative 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.

Countries

China

Contacts

Primary ContactKangjie Xie, MD
xiekj@zjcc.org.cn8613516721870

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026