Atherolive: Olive Leaf Extracts in the Control of Cardiovascular Risk
Study Details
Study Description
Brief 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:
-
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
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:
-
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 )
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: atherolive group 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
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.
|
| Placebo Comparator: placebo group 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
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.
|
Outcome Measures
Primary Outcome Measures
- rate of blood pressure reduction [90 days]
blood pressure reduction on 24 hours holter
- rate of fasting glycemia level reduction [90 days]
morning glycemic cycle
Secondary Outcome Measures
- rate of lipid balance variation The secondary endpoint (for the 3 study populations): lipid profile [90 days]
variation in lipid balance
- rate of hospitalization for cardiovascular disease [90 days]
rate of hospitalization for cardiovascular disease: acute infarction, hypertension, acute stroke
- rate of adverse effects [90 days]
number of adeverse evnets reported
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fattouma Bourguiba Monastir University Hospital Center | Monastir | Tunisia | 5000 |
Sponsors and Collaborators
- University of Monastir
Investigators
- Principal Investigator: Nouira Semir, Professor, University of Monastir
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Atherolive