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

Primary Purpose

Diabetes Mellitus, Type 2, Hypertension

Status
Recruiting
Phase
Phase 2
Locations
Tunisia
Study Type
Interventional
Intervention
atherolive
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, hypertension, atherolive

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fattouma Bourguiba Monastir University Hospital CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

atherolive group

placebo group

Arm 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.

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.

Outcomes

Primary Outcome Measures

rate of blood pressure reduction
blood pressure reduction on 24 hours holter
rate of fasting glycemia level reduction
morning glycemic cycle

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2021
Last Updated
January 3, 2023
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT05297110
Brief Title
Olive Leaf Extracts in the Control of Cardiovascular Risk
Acronym
Atherolive
Official Title
Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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 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: The population of patients with hypertension. The population with diabetes. 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 )

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertension
Keywords
diabetes, hypertension, atherolive

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
atherolive group
Arm Type
Active Comparator
Arm 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.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
atherolive
Intervention 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.
Primary Outcome Measure Information:
Title
rate of blood pressure reduction
Description
blood pressure reduction on 24 hours holter
Time Frame
90 days
Title
rate of fasting glycemia level reduction
Description
morning glycemic cycle
Time Frame
90 days
Secondary Outcome Measure Information:
Title
rate of lipid balance variation The secondary endpoint (for the 3 study populations): lipid profile
Description
variation in lipid balance
Time Frame
90 days
Title
rate of hospitalization for cardiovascular disease
Description
rate of hospitalization for cardiovascular disease: acute infarction, hypertension, acute stroke
Time Frame
90 days
Title
rate of adverse effects
Description
number of adeverse evnets reported
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Criteria exclusion: -. Exclusion criteria: None.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nouira Semir, Pr
Phone
73106046
Ext
216
Email
semir.nouira@rns.tn
First Name & Middle Initial & Last Name or Official Title & Degree
Bel Hadj Ali Khaoula, Pr
Phone
73106046
Ext
216
Email
belhadjalikhaoula@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Semir, Professor
Organizational Affiliation
University of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fattouma Bourguiba Monastir University Hospital Center
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nouira Semir, PhD
Phone
73106046
Email
semir.nouira@rns.tn

12. IPD Sharing Statement

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Olive Leaf Extracts in the Control of Cardiovascular Risk

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