Olive Leaf Extracts in the Control of Cardiovascular Risk (Atherolive)

University of Monastir

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Hypertension; Diabetes Mellitus, Type 2

Treatments: Drug: atherolive

Study type: Interventional

Funder types: Other

Identifiers

NCT05297110

Atherolive

Details and patient eligibility

About

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.

Full 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 )

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.

Criteria exclusion:

-. Exclusion criteria: None.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups, including a placebo group

atherolive group

Active Comparator group

Description:

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.

Treatment:

Drug: atherolive

placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: atherolive