Diabetes Mellitus, Type 2, Hypertension
Conditions
Keywords
diabetes, hypertension, atherolive
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 )
Interventions
DRUGatherolive
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.
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of blood pressure reduction | 90 days | blood pressure reduction on 24 hours holter |
| rate of fasting glycemia level reduction | 90 days | morning glycemic cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of lipid balance variation The secondary endpoint (for the 3 study populations): lipid profile | 90 days | variation in lipid balance |
| rate of hospitalization for cardiovascular disease | 90 days | rate of hospitalization for cardiovascular disease: acute infarction, hypertension, acute stroke |
| rate of adverse effects | 90 days | number of adeverse evnets reported |
Countries
Tunisia
Contacts
Primary ContactNouira Semir, Pr
Backup ContactBel Hadj Ali Khaoula, Pr
Outcome results
None listed