Olive Leaf Extracts in the Control of Cardiovascular Risk — Atherolive  

Hypertension Clinical Trial

Official title: Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 ) ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension

• NCT number: NCT05297110
• Study type: Interventional
• Source: University of Monastir
• Contact: Nouira Semir, Pr
• Phone: 73106046
• Email: semir.nouira@rns.tn
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2021
• Completion date: December 1, 2023