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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426953
• Other study ID #: IRB-2024-467(IIT)
• Status: Recruiting
• Start date: May 20, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The study was a single-center, prospective，single blind (blinded to subjects and evaluators)，control, observational clinical study. We 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Emergence Delirium
• Postoperative Delirium

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Xie Kangjie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the relationship between POD and TGF-ß, INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, pgc-1a) in diabetic patients.	The related proteins were detected by ELISA	2024-05 to 2026-06