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

NCT ID: NCT06426953

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-20

Study Completion Date

2026-08-30

Brief Summary

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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

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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.

Conditions

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Diabetes Postoperative Delirium

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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

Diabetic patients with a history of more than 2 years

No intervention

Intervention Type OTHER

No intervention

No history of diabetes and normal blood glucose

Patients without a history of diabetes

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xie Kangjie

OTHER

Sponsor Role lead

Responsible Party

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Xie Kangjie

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kangjie Xie, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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The People's hospital of Qiannan

Duyun, Guizhou, China

Site Status NOT_YET_RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kangjie Xie, MD

Role: CONTACT

8613516721870

Facility Contacts

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Kai He, MD

Role: primary

Kangjie Xie, MD

Role: primary

008613516721870

Other Identifiers

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IRB-2024-467(IIT)

Identifier Type: -

Identifier Source: org_study_id

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