- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07928453
Cardiovascular And Dementia Risk in diabeTes: the Role of Nox2- Related Oxidative Stress. (CARTESIO)
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Daniele Pastori, MD, PhD
- Telefonnummer: 003908659291
- E-post: daniele.pastori@uniroma1.it
Studieorter
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Pozzilli, Italien
- Rekrytering
- Neuromed Irccs
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Kontakt:
- Direzione Scientifica
- Telefonnummer: +0390865 929600
- E-post: direzionescientifica@neuromed.it
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patients with diabetes attending outpatients clinic
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: OTHER
- Tidsperspektiv: OTHER
Kohorter och interventioner
Grupp / Kohort |
|---|
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Study group
Patients with diabetes with cognitive impairment |
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Control group
Patients with diabetes without cognitive impairment |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Multidimensional geriatric assessment (MGA): MMSE
Tidsram: 18 months
|
T2D patients, with or without cognitive impairment will undergo the Mini-Mental State Examination (MMSE) |
18 months
|
|
Multidimensional geriatric assessment (MGA): MoCA
Tidsram: 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
Tidsram: 18 months
|
T2D patients, with or without cognitive impairment will undergo the Short Portable Mental State Questionary (SPMSQ) |
18 months
|
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Multidimensional geriatric assessment (MGA): SBT
Tidsram: 18 months
|
T2D patients, with or without cognitive impairment will undergo the Short Blessed Test (SBT) |
18 months
|
|
Lifestyle habits: nutritional assessment
Tidsram: 18 months
|
T2D patients, with or without cognitive impairment will undergo the Mini Nutritional Assessment (MNA) |
18 months
|
|
Lifestyle habits: daily activity
Tidsram: 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
|
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Cognitive function evaluation: biomarker BDNF
Tidsram: 18 months
|
T2D patients, with or without cognitive impairment will undergo the dosage of BDNF and ß-amyloid 42/40 |
18 months
|
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Cognitive function evaluation: biomarker ß-amyloid 42/40
Tidsram: 18 months
|
T2D patients, with or without cognitive impairment will undergo the dosage of ß-amyloid 42/40 |
18 months
|
|
NOX2-mediated oxidative stress
Tidsram: 18 months
|
soluble sNOX2-dp by ELISA test |
18 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Thrombus formation
Tidsram: 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
Tidsram: 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
|
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Endothelial dysfunction: FMD
Tidsram: 18 months
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Endothelial function study by flow-mediated dilation (FMD) analysis |
18 months
|
|
Endothelial dysfunction: VWF
Tidsram: 18 months
|
Endothelial function will be evaluated by von Willebrand factor (VWF) levels |
18 months
|
|
Endothelial dysfunction: ET1
Tidsram: 18 months
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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
|
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In vitro study - HUVEC
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PNRR-MCNT1-2023-12377768
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