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Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors
This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital). Patients over 18 years of age with: 1. Arterial hypertension (hypertension). 2. Or diabetes. 3. Or one or more other cardiovascular risk factors (AHA, ESC) or risk of cardiovascular disease\> 20% according to the Framingham scale (apart from hypertension and diabetes were included.
This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital). All the population will benifit of a biological assessment which include: * Complete lipid profile, blood sugar, creatinine * HbA1c (if the patient is diabetic). * Inflammatory assessment: reactive protein C Three populations will be randomized: 1. The population of patients with hypertension. 2. The population with diabetes. 3. The population of patients with other risk factors with a Framingham\> 20% In each study population, the patient will be assigned to one of two treatments (atherolive or placebo). The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically. For patients in the hypertension group: A blood pressure or glycemic holter will be carried out for 24 hours respectively and diabetics. The raw data (hourly averages) are stored on a computer . For diabetic patients: Continuous blood glucose monitoring to measure indices of glycemic variability is performed at baseline. These patients will be equipped with an iPro continuous glycemic monitoring For other patients (Framingham\> 20%) For this group, the initial assessment will also include a specific assessment. Assessment of endothelial function by the digital plethysmography method to measure flow-mediated dilation (FMD or flow-mediated dilation expressed by the RHI) and specific biological assesement ( Willebrand factor, Homocystein )
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
Yes
Fattouma Bourguiba Monastir University Hospital Center
Monastir, Tunisia
Start Date
August 1, 2021
Primary Completion Date
November 1, 2023
Completion Date
December 1, 2023
Last Updated
January 4, 2023
1,000
ESTIMATED participants
atherolive
DRUG
Lead Sponsor
University of Monastir
NCT02417740
NCT07073820
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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