Cardiovascular And Dementia Risk in diabeTes: the Role of Nox2- Related Oxidative Stress.
NCT07928453, Recruiting, Neuromed IRCCS
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cardiovascular And Dementia Risk in diabeTes: the Role of Nox2- Related Oxidative Stress. | ClinicalTrials.gov |
| NCT number | NCT07928453 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 250 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Neuromed IRCCS | ClinicalTrials.gov |
| Conditions | Diabetes in Adults, Dementia, Oxidative Stress | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Multidimensional geriatric assessment (MGA): MMSE | 18 months | T2D patients, with or without cognitive impairment will undergo the Mini-Mental State Examination (MMSE) | ClinicalTrials.gov |
| Primary | Multidimensional geriatric assessment (MGA): MoCA | 18 months | T2D patients, with or without cognitive impairment will undergo the MoCA (Montreal Cognitive Assessment or The MoCA Test | ClinicalTrials.gov |
| Primary | Multidimensional geriatric assessment (MGA): SPMSQ | 18 months | T2D patients, with or without cognitive impairment will undergo the Short Portable Mental State Questionary (SPMSQ) | ClinicalTrials.gov |
| Primary | Multidimensional geriatric assessment (MGA): SBT | 18 months | T2D patients, with or without cognitive impairment will undergo the Short Blessed Test (SBT) | ClinicalTrials.gov |
| Primary | Lifestyle habits: nutritional assessment | 18 months | T2D patients, with or without cognitive impairment will undergo the Mini Nutritional Assessment (MNA) | ClinicalTrials.gov |
| Primary | Lifestyle habits: daily activity | 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 | ClinicalTrials.gov |
| Primary | Cognitive function evaluation: biomarker BDNF | 18 months | T2D patients, with or without cognitive impairment will undergo the dosage of BDNF and ß-amyloid 42/40 | ClinicalTrials.gov |
| Primary | Cognitive function evaluation: biomarker ß-amyloid 42/40 | 18 months | T2D patients, with or without cognitive impairment will undergo the dosage of ß-amyloid 42/40 | ClinicalTrials.gov |
| Primary | NOX2-mediated oxidative stress | 18 months | soluble sNOX2-dp by ELISA test | ClinicalTrials.gov |
| Secondary | Thrombus formation | 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). | ClinicalTrials.gov |
| Secondary | Experimental mice models: NOX2 pathway | 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. | ClinicalTrials.gov |
| Secondary | Endothelial dysfunction: FMD | 18 months | Endothelial function study by flow-mediated dilation (FMD) analysis | ClinicalTrials.gov |
| Secondary | Endothelial dysfunction: VWF | 18 months | Endothelial function will be evaluated by von Willebrand factor (VWF) levels | ClinicalTrials.gov |
| Secondary | Endothelial dysfunction: ET1 | 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 | ClinicalTrials.gov |
| Secondary | In vitro study - HUVEC | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)