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Cardiovascular And Dementia Risk in diabeTes: the Role of Nox2- Related Oxidative Stress. (CARTESIO)

2026年11月3日 更新者:Daniele Pastori、Neuromed IRCCS

Cardiovascular And Dementia Risk in diabeTes Experimental and Clinical Study: Investigation on Nox2- Related Oxidative Stress (CARTESIO).

The prevalence of dementia and diabetes has increased in recent decades. The WHO forecasts an increase in the all-cause dementia prevalence to 152 million by 2050. Type 2 diabetes (T2D) is a well-known risk factor for dementia. The prevalence of T2D was estimated to be 6.28% (462 million people) worldwide, and 22% among people aged 70 years and older. Even pre-diabetes has been shown to be a risk factor for all-cause dementia, Alzheimer¿s disease (AD) and vascular dementia (VD).

There are various mechanisms by which T2D and dementia are connected. First, there are atherosclerotic consequences of T2D that favour VD. T2D is strongly associated with micro- and macrovascular diseases. This association is essentially determined by diabetes duration. Oxidative stress is the direct result of the imbalance between the production of reactive oxygen species (ROS) and intracellular antioxidant defences. It is involved in the onset of diabetes and neurological pathologies such as AD, Parkinson¿s disease, and amyotrophic lateral sclerosis. Therefore, as oxidative stress is a common pathway in diabetes and dementia, the evaluation of oxidative stress, using specific and direct biomarkers, is necessary to monitor the risk of dementia in patients with diabetes. Furthermore, it is important to study the mechanisms that lead to changes in the oxidative state, in order to define new therapeutic targets that allow delaying the eventual onset of dementia.

This project aims at defining how 1) soluble (s)NOX2-derived peptide(dp), a new direct biomarker of oxidative stress, could be used to stratify the risk of dementia in T2D patients; 2) if p47phox, a key cytosolic subunit that drives NOX2 activation, could be considered a therapeutic target to reduce oxidative stress-mediated dementia in T2D.

A clinical Aim will collect data of a T2D population to evaluate cognitive function, by the Multidimensional geriatric assessment (MGA) and cognitive biomarkers such as brain-derived neurotrophic factor (BDNF) and ß-amyloid 42/40 and oxidative stress by sNOX2dp.

A second Aim will explore the contribution of NOX2 activation in the thrombotic process and cognitive impairment in T2D patients by the evaluation of endothelial dysfunction, as a thrombogenic risk factor, and quantitative analysis of the thrombus formation process.

Finally, a preclinical Aim will test the hypothesis that p47phox could be a therapeutic target to prevent oxidative stress-mediated dementia in T2D. Specifically, we tested the effects of the p47phox inhibitor peptide both in vitro, in human umbilical vein endothelial cells (HUVEC), and in animal models (C57BL/6J) of high-fat diet (HFD)-induced diabetes.

Considering the prevalence of dementia in T2D and the uncertainty in their management, the proposed work is expected to generate results of immediate clinical significance.

研究概览

地位

招聘中

研究类型

观察性的

注册 (估计的)

250

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with diabetes attending outpatients clinic

描述

Inclusion Criteria:

  • Established diagnosis of T2D according to the 2019 ESC guidelines
  • Written informed consent obtained from the patient before enrollment
  • Antidiabetic drug-naive, or treated with one or two oral anti-diabetic drugs, or treated with human NPH insulin or longacting insulin analogue or pre-mixed insulin, alone or in combination with one or two oral anti-diabetic drugs
  • Age >50 years

Exclusion Criteria:

  • - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening
  • HbA1c >10%
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • History of ischemic stroke or transient ischemic attack
  • Acute coronary event within 30 days before enrolment
  • Currently planned coronary, carotid or peripheral artery revascularization
  • Chronic Heart Failure NYHA Class IV
  • End-stage liver disease, defined as the presence of acute or chronic liver disease and recent history of one or more of the following: ascites, encephalopathy, variceal bleeding, bilirubin >2.0 mg/dL, albumin level <3.5 g/dL, prothrombin time >4 seconds prolonged, international normalised ratio (INR) >1.7 or prior liver transplant
  • End-stage chronic kidney disease (eGFR <30 ml/min)
  • Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years
  • Life expectancy <2 years (and in any case before the completion of the study)
  • Low adherence to prescribed medications
  • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
  • Use of oral anticoagulants (atrial fibrillation of venous thromboembolism)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:OTHER
  • 时间观点:OTHER

队列和干预

团体/队列
Study group

Patients with diabetes with cognitive impairment

Control group

Patients with diabetes without cognitive impairment

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Multidimensional geriatric assessment (MGA): MMSE
大体时间:18 months

T2D patients, with or without cognitive impairment will undergo the Mini-Mental State Examination (MMSE)

18 months
Multidimensional geriatric assessment (MGA): MoCA
大体时间:18 months

T2D patients, with or without cognitive impairment will undergo the MoCA (Montreal Cognitive Assessment or The MoCA Test

18 months
Multidimensional geriatric assessment (MGA): SPMSQ
大体时间:18 months

T2D patients, with or without cognitive impairment will undergo the Short Portable Mental State Questionary (SPMSQ)

18 months
Multidimensional geriatric assessment (MGA): SBT
大体时间:18 months

T2D patients, with or without cognitive impairment will undergo the Short Blessed Test (SBT)

18 months
Lifestyle habits: nutritional assessment
大体时间:18 months

T2D patients, with or without cognitive impairment will undergo the Mini Nutritional Assessment (MNA)

18 months
Lifestyle habits: daily activity
大体时间:18 months

T2D patients, with or without cognitive impairment will undergo the Basic Activities of Daily Living (BADL), cognitive biomarker BDNF and ß-amyloid 42/40

18 months
Cognitive function evaluation: biomarker BDNF
大体时间:18 months

T2D patients, with or without cognitive impairment will undergo the dosage of BDNF and ß-amyloid 42/40

18 months
Cognitive function evaluation: biomarker ß-amyloid 42/40
大体时间:18 months

T2D patients, with or without cognitive impairment will undergo the dosage of ß-amyloid 42/40

18 months
NOX2-mediated oxidative stress
大体时间:18 months

soluble sNOX2-dp by ELISA test

18 months

次要结果测量

结果测量
措施说明
大体时间
Thrombus formation
大体时间:18 months

T2D patients, with or without cognitive impairment will undergo evaluation of thrombus formation process will be assessed by quantitative analysis by "Total Thrombus formation Analysis System (TTAS).

18 months
Experimental mice models: NOX2 pathway
大体时间:18 months

The role of NOX2 will be studied by comparing p47phox-/- mice and wild-type C57BL/6J adult mice. p47phox is the cytosolic subunit of phagocyte NOX2, and is required for its activation and subsequent production of superoxide.

Diabetes in p47phox-/- mice and in wild-type C57BL/6J adult mice will be induced by the administration of a high-fat diet (HFD) for 8 weeks.

18 months
Endothelial dysfunction: FMD
大体时间:18 months

Endothelial function study by flow-mediated dilation (FMD) analysis

18 months
Endothelial dysfunction: VWF
大体时间:18 months

Endothelial function will be evaluated by von Willebrand factor (VWF) levels

18 months
Endothelial dysfunction: ET1
大体时间:18 months

Endothelial function will be evaluated by circulating biomarkers such as endothelin 1, whose enhanced activity and/or levels have been associated to endothelial dysfunction in the insulin-resistant states of obesity and type 2 diabetes

18 months
In vitro study - HUVEC
大体时间:18 months

The effects of p47phox IP will be studied in vitro in human umbilical vein endothelial cells (HUVEC). HUVEC will be challenged with scalar concentrations of glucose or vehicle. Cell viability will be investigated by FACS analysis. Nitric oxide (NO) production will be measured by diaminofluorescein-FM diacetate and nitrite/nitrate assay, and NOX2 activity will be assessed by ELISA test of conditioned media. The effects of p47phox IP angiogenesis will be also tested in HUVEC subjected to high-glucose stimulation

18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年8月31日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年2月28日

研究注册日期

首次提交

2026年10月26日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • PNRR-MCNT1-2023-12377768

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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