Status:
COMPLETED
Effects of Trehalose and Polyphenols in Vasculopathic Patients
Lead Sponsor:
University of Roma La Sapienza
Collaborating Sponsors:
Peruzzi Mariangela
Conditions:
Oxidative Stress
Cardiovascular Diseases
Eligibility:
All Genders
60-80 years
Phase:
NA
Brief Summary
Peripheral arterial disease (PAD) is an important manifestation of systemic atherosclerosis and is characterized by obstruction of the arteries of the lower extremities. PAD is usually associated with...
Detailed Description
Peripheral arterial disease (PAD) is an important manifestation of systemic atherosclerosis and is characterized by obstruction of the arteries of the lower limbs. PAD is usually associated with vascu...
Eligibility Criteria
Inclusion
- Inclusion Criteria for PAD patients (n=40):
- claudication (defined as pain in the legs during walking which disappears within 10 minutes of standing);
- ankle/brachial index (ABI), evaluated as an ankle/arm systolic blood pressure ratio using Doppler ultrasound on the worst resting leg;
- stable condition without sudden changes in ABI (\> 20%) in the last month before enrollment
- Inclusion criteria for hypertensive patients (n=40):
- Office systolic BP (SBP) values ≥140 mmHg and/or diastolic BP (DBP) values ≥90 mmHg (average of 3 repeated measurements made by the same doctor with an oscillometric automatic sphygmomanometer). Treatment with antihypertensive drugs, namely ACE inhibitors (ACEi), angiotensin receptor blockers (ARB), calcium channel blockers (CCB), thiazide/thiazide-like diuretics, loop diuretics, mineralocorticoid receptor antagonists (MRA), beta-blockers and alpha-blockers, were considered hypertensives.
- Exclusion Criteria for PAD patients:
- liver failure;
- severe kidney disorders (serum creatinine \[mt\] 2.8 mg / dL);
- acute cerebrovascular disease;
- acute myocardial infarction;
- smokers;
- patients under treatment with antioxidants for at least 30 days before enrollment
- Exclusion criteria for hypertensive patients:
- Patients with diabetes mellitus or known history of ischemic heart disease, peripheral artery disease, and chronic renal failure were excluded.
Exclusion
Key Trial Info
Start Date :
December 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04061070
Start Date
December 12 2019
End Date
April 30 2021
Last Update
June 18 2023
Active Locations (2)
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1
Umberto I Policlinico di Roma, Sapienza Università di Roma
Roma, Italia, Italy, 00155
2
Umberto I Policlinico di Roma, Sapienza Università di Roma
Rome, Italy, 00155