Olive Leaf Extracts in the Control of Cardiovascular Risk

Phase 2

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Hypertension
• Interventions: Drug: atherolive

• Registration Number: NCT05297110
• Lead Sponsor: University of Monastir

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:

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 )

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atherolive group	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 group	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Fattouma Bourguiba Monastir University Hospital Center; 🇹🇳 Monastir, Tunisia