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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    1000
  • sponsor
    University of Monastir
Updated on 7 April 2022
diabetes
cardiovascular disease
hypertension
Accepts healthy volunteers

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 )

Details
Condition Diabetes Mellitus, Type 2, Hypertension
Treatment atherolive
Clinical Study IdentifierNCT05297110
SponsorUniversity of Monastir
Last Modified on7 April 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Exclusion criteria: None
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