NCT05297110

Olive Leaf Extracts in the Control of Cardiovascular Risk

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed 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 )

Conditions

• Diabetes Mellitus, Type 2
• Hypertension

Interventions

Type	Name	Description
DRUG	atherolive	In each study population, the patient will be assigned to one of two treatments (atherolive or placebo) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. 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.

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2022-03-28
• Last updated: 2023-01-04

Locations

1 site across 1 country: Tunisia