Clinical trial NCT05297110: Olive Leaf Extracts in the Control of Cardiovascular Risk
Official title: Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 2
Hypertension
Keywords: diabetes
hypertension
atherolive
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 )

Eligibility 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.

Primary outcomes:
measure: rate of blood pressure reduction
timeFrame: 90 days
measure: rate of fasting glycemia level reduction
timeFrame: 90 days
Secondary outcomes:
measure: rate of lipid balance variation The secondary endpoint (for the 3 study populations): lipid profile
timeFrame: 90 days
measure: rate of hospitalization for cardiovascular disease
timeFrame: 90 days
measure: rate of adverse effects
timeFrame: 90 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba Monastir University Hospital Center
Study officials:
affiliation: University of Monastir
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References: