## Protocol Section
### Identification Module
**NCT ID:** NCT06426953

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

**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

#### Organization Study ID Info
**ID:** IRB-2024-467（IIT）
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Xie Kangjie

#### Responsible Party

**Investigator Affiliation:** Zhejiang Cancer Hospital

**Investigator Full Name:** Xie Kangjie

**Investigator Title:** MD

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 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.

### Conditions Module

**Conditions:**

- Diabetes

- Postoperative Delirium

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 180

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: No intervention

**Label:** History of diabetes ≥2 years and Glycated hemoglobin ≥6.5%

#### Arm Group 2

**Intervention Names:**

- Other: No intervention

**Label:** No history of diabetes and normal blood glucose

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

- No history of diabetes and normal blood glucose

**Description:** No intervention

**Name:** No intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The related proteins were detected by ELISA

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

**Time Frame:** 2024-05 to 2026-06

### Eligibility Module

**Eligibility 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)

**Minimum Age:** 65 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

**Study Population:** Elderly patients with a history of diabetes ≥2 years and a glycated hemoglobin of ≥6.5% or without a history of diabetes and a normal blood glucose level

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Email:** xiekj@zjcc.org.cn

- **Name:** XIE Kangjie, MD

- **Phone:** 13516721870

- **Role:** CONTACT

**Country:** China

**Facility:** Zhejiang Cancer Hospital

**State:** Zhejang

**Status:** RECRUITING

**Zip:** 310000

**Location 2:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Email:** xiekj@zjcc.org.cn

- **Name:** Kangjie Xie, MD

- **Phone:** 008613516721870

- **Role:** CONTACT

**Country:** China

**Facility:** Zhejiang Cancer Hospital

**State:** Zhejiang

**Status:** RECRUITING

**Zip:** 310022

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000003693

- Term: Delirium

- ID: D000003221

- Term: Confusion

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M6894

- Name: Delirium

- Relevance: LOW

- As Found: Unknown

- ID: M772

- Name: Emergence Delirium

- Relevance: HIGH

- As Found: Postoperative Delirium

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6446

- Name: Confusion

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: T929

- Name: Camurati-Engelmann Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000071257

- Term: Emergence Delirium

- ID: D000003920

- Term: Diabetes Mellitus

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M207501

- Name: Chrysarobin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
