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

Xie Kangjie

Status: Enrolling

Conditions: Diabetes; Postoperative Delirium

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06426953

IRB-2024-467（IIT）

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

180 participants in 2 patient groups

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

Description:

Diabetic patients with a history of more than 2 years

Treatment:

Other: No intervention

No history of diabetes and normal blood glucose

Description:

Patients without a history of diabetes

Treatment:

Other: No intervention