Diabetes, Dementia, and Oxidative Stress: A look at Nox2-related markers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study explores the connection between diabetes, oxidative stress, and dementia risk by examining Nox2-related markers in adults with type 2 diabetes. Participants are adults over 50 with established T2D who meet specific medication and health criteria. The research looks at how oxidative stress might link diabetes duration and vascular or neurodegenerative outcomes, using biomarkers and health data collected under real-world conditions. It is not a treatment trial and does not assign experimental therapies. Findings could clarify potential mechanisms and identify biomarkers for dementia risk in diabetes.

Why it matters

Who can join: the full rules

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)

Where it's running

• Neuromed Irccs
  Pozzilli, Italy Recruiting

Study contacts

• Study coordinator: Daniele Pastori, MD, PhD
• Email: daniele.pastori@uniroma1.it
• Phone: 003908659291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.