Olive Leaf Extracts in the Control of Cardiovascular Risk

Study Overview
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Brief Summary
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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: Arterial hypertension (hypertension). Or diabetes. 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
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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: The population of patients with hypertension. The population with diabetes. 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 )

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

Conditions
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Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Drug: atherolive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age with: Arterial hypertension (hypertension). Or diabetes. 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. Criteria exclusion: -. Exclusion criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: atherolive group<br>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. | Drug: atherolive<br>* 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.<br>|
| Placebo Comparator: placebo group<br>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. | Drug: atherolive<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of blood pressure reduction | blood pressure reduction on 24 hours holter | 90 days | 
| rate of fasting glycemia level reduction | morning glycemic cycle | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of lipid balance variation The secondary endpoint (for the 3 study populations): lipid profile | variation in lipid balance | 90 days | 
| rate of hospitalization for cardiovascular disease | rate of hospitalization for cardiovascular disease: acute infarction, hypertension, acute stroke | 90 days | 
| rate of adverse effects | number of adeverse evnets reported | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, hypertension, atherolive