Investigating proteins related to postoperative delirium 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
This study is trying to see if certain proteins in the blood are linked to confusion after surgery in people with diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Locations | 2 sites (Duyun, Guizhou and 1 other locations) |
| Trial ID | NCT06426953 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between postoperative delirium (POD) and specific proteins associated with the TGF-β and INS-PI3K-AKT signaling pathways in patients with diabetes. Conducted at two centers, the study involves collecting blood samples from participants before surgery to analyze levels of proteins such as ADNP, MAP6, and PGC-1α using ELISA. The study is designed to be single-blind, meaning that subjects and evaluators are unaware of the specific details of the study to minimize bias.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older with a history of diabetes for at least two years.
Not a fit: Patients with severe neurological or psychiatric conditions, or those with significant cardiac or renal dysfunction, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better predictive markers for postoperative delirium in diabetic patients, potentially improving patient outcomes.
How similar studies have performed: While this study explores a specific relationship, similar studies have shown promise in identifying biomarkers for postoperative complications, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Duyun, Guizhou and 1 other locations
- The People's hospital of Qiannan — Duyun, Guizhou, China (Not_yet_recruiting)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Kangjie Xie, MD — Zhejiang Cancer Hospital
- Study coordinator: Kangjie Xie, MD
- Email: xiekj@zjcc.org.cn
- Phone: 8613516721870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.