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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:
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:
Three populations will be randomized:
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 )
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| atherolive group | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atherolive | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of blood pressure reduction | blood pressure reduction on 24 hours holter | 90 days |
| rate of fasting glycemia level reduction | morning glycemic cycle | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| rate of lipid balance variation The secondary endpoint (for the 3 study populations): lipid profile | variation in lipid balance | 90 days |
| rate of hospitalization for cardiovascular disease | rate of hospitalization for cardiovascular disease: acute infarction, hypertension, acute stroke |
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Inclusion Criteria:
Patients over 18 years of age with:
Criteria exclusion:
-. Exclusion criteria: None.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nouira Semir, Pr | Contact | 73106046 | 216 | semir.nouira@rns.tn |
| Bel Hadj Ali Khaoula, Pr | Contact | 73106046 | 216 | belhadjalikhaoula@yahoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nouira Semir, Professor | University of Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fattouma Bourguiba Monastir University Hospital Center | Recruiting | Monastir | 5000 | Tunisia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 90 days |
| rate of adverse effects | number of adeverse evnets reported | 90 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |