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

3. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

250

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Patients with diabetes attending outpatients clinic

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: OTHER
  • Zeitperspektiven: OTHER

Kohorten und Interventionen

Gruppe / Kohorte
Study group

Patients with diabetes with cognitive impairment

Control group

Patients with diabetes without cognitive impairment

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Multidimensional geriatric assessment (MGA): MMSE
Zeitfenster: 18 months

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

18 months
Multidimensional geriatric assessment (MGA): MoCA
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 18 months

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

18 months
Lifestyle habits: nutritional assessment
Zeitfenster: 18 months

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

18 months
Lifestyle habits: daily activity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 18 months

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

18 months
NOX2-mediated oxidative stress
Zeitfenster: 18 months

soluble sNOX2-dp by ELISA test

18 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Thrombus formation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 18 months

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

18 months
Endothelial dysfunction: VWF
Zeitfenster: 18 months

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

18 months
Endothelial dysfunction: ET1
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mitarbeiter

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

31. August 2024

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

28. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

26. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. November 2026

Zuerst gepostet (Tatsächlich)

10. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • PNRR-MCNT1-2023-12377768

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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