DiabetesNCT06426953
Predictive Effect of TGF-β and INS-PI3K-AKT Related Proteins for POD in Diabetes Patients
An observational study of Diabetes and Postoperative Delirium, run by Xie Kangjie at 2 sites in China.
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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes, Postoperative Delirium
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 20 May 2024to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- 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
Who may be able to join
- Age ≥65 years
- History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% or no history of diabetes and normal blood glucose
- The ASA rating is Class I to III
- The elderly patients of limited thoracic and abdominal tumor surgery
Who cannot join
- Refused to participate
- Previous history of schizophrenia, epilepsy, Parkinson's disease
- History of alcohol abuse or drug dependence
- Patients with ASA grade IV and above
- Severe visual or hearing impairment, can not cooperate with the completion of cognitive function tests
- Participants in other clinical trials within the last two months
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- Patients with severe arrhythmia or cardiac dysfunction(EF<40%)
- There was a clear history of neurological and psychiatric problems or long-term use of sedatives or antidepressants
- History of cerebrovascular disease or brain surgery or trauma
- Severe liver dysfunction (Child-Pugh class C) or severe renal dysfunction (requiring dialysis)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
The People's hospital of Qiannan
Duyun, Guizhou, 558000
Kai He, MD
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Kangjie Xie, MD, 008613516721870, xiekj@zjcc.org.cn
About this study
Official title: Predictive Effect of TGF-β Combined With INS-PI3K-AKT Signaling Pathway Related Proteins (ADNP, MAP6, Pgc-1α) for POD in Diabetes Patients
To investigate the relationship between POD, TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) in diabetic patients
Read the detailed 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.
- Conditions
- Diabetes, Postoperative Delirium
- Being tested
- No intervention
- Medical subject headings
- Diabetes Mellitus, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% | Diabetic patients with a history of more than 2 years Receives: Other: No intervention | |
| No history of diabetes and normal blood glucose | Patients without a history of diabetes Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between preoperative plasma levels of TGF-β, ADNP, MAP6, PGC-1α and the incidence of delirium within 3 days after operation was analyzed.
Postoperative delirium (POD) was assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM).
Transforming growth factor-beta (TGF-β), activity-dependent neuroprotective protein (ADNP), microtubule-associated protein 6 (MAP6), and peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) levels were measured using enzyme-linked immunosorbent assay (ELISA) kits.
Measured: 2024-05 to 2026-06
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start20 May 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xie Kangjie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xie Kangjie, Zhejiang Cancer Hospital
- Investigators
- Kangjie Xie, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426953
- Sponsor's protocol ID
- IRB-2024-467（IIT）
- Status last verified
- Dec 2024
- First submitted
- 19 May 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Effect of TGF-β Combined With INS-PI3K-AKT Signaling Pathway Related Proteins (ADNP, MAP6, Pgc-1α) for POD in Diabetes Patients
- ClinicalTrials.gov ID
- NCT06426953
- Acronym / sponsor ID
- IRB-2024-467（IIT）
- Conditions
- Diabetes, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Xie KangjieUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% | – | Other: No interventionDiabetic patients with a history of more than 2 years |
| No history of diabetes and normal blood glucose | – | Other: No interventionPatients without a history of diabetes |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- Age ≥65 years
- History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% or no history of diabetes and normal blood glucose
- The ASA rating is Class I to III
- The elderly patients of limited thoracic and abdominal tumor surgery
Key exclusion criteria (10 listed)
- Refused to participate
- Previous history of schizophrenia, epilepsy, Parkinson's disease
- History of alcohol abuse or drug dependence
- Patients with ASA grade IV and above
- Severe visual or hearing impairment, can not cooperate with the completion of cognitive function tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | History of diabetes ≥2 years and Glycated hemoglobin ≥6.5%, No history of diabetes and normal blood glucose |
Primary outcome
The correlation between preoperative plasma levels of TGF-β, ADNP, MAP6, PGC-1α and the incidence of delirium within 3 days after operation was analyzed.
Time frame: 2024-05 to 2026-06
Postoperative delirium (POD) was assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM). Transforming growth factor-beta (TGF-β), activity-dependent neuroprotective protein (ADNP), microtubule-associated protein 6 (MAP6), and peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) levels were measured using enzyme-linked immunosorbent assay (ELISA) kits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kangjie Xie, MD principal investigator
Zhejiang Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Postoperative Delirium, run by Xie Kangjie at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kangjie Xie, MD (8613516721870, xiekj@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between preoperative plasma levels of TGF-β, ADNP, MAP6, PGC-1α and the incidence of delirium within 3 days after operation was analyzed. (time frame: 2024-05 to 2026-06). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.