Olive Leaf Extracts in the Control of Cardiovascular Risk

Hypertension Clinical Trial

— Atherolive  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05297110
• Other study ID #: Atherolive
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: University of Monastir
• Contact: Nouira Semir, Pr
• Phone: 73106046
• Email: semir.nouira[@]rns.tn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 )

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba Monastir University Hospital Center	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of blood pressure reduction	blood pressure reduction on 24 hours holter	90 days
Primary	rate of fasting glycemia level reduction	morning glycemic cycle	90 days
Secondary	rate of lipid balance variation The secondary endpoint (for the 3 study populations): lipid profile	variation in lipid balance	90 days
Secondary	rate of hospitalization for cardiovascular disease	rate of hospitalization for cardiovascular disease: acute infarction, hypertension, acute stroke	90 days
Secondary	rate of adverse effects	number of adeverse evnets reported	90 days