Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
500 participants
INTERVENTIONAL
2023-01-01
2025-12-15
Brief Summary
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Patients over 18 years of age with:
-Diabets
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Detailed Description
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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 One population will be rendomized:The population with diabetes. 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.
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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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atherolive
In this Arm the patient will receive the study drug (atherol) that will be prescribed at a dose of 400 mg, once a day for 3 months.
Atherolive
The patient will be assigned 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.
placebo atherolive
In this Arm patients will receive the placebo at a dose of 400 mg once a day for 3 months.
Placebo Atherolive
The patient will be assigned 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 placebo will be prescribed at a dose of 400 mg once a day for 3 months.
Interventions
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Atherolive
The patient will be assigned 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.
Placebo Atherolive
The patient will be assigned 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 placebo will be prescribed at a dose of 400 mg once a day for 3 months.
Eligibility Criteria
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Inclusion Criteria
* diabetes.
18 Years
100 Years
ALL
No
Sponsors
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University of Monastir
OTHER
Responsible Party
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Pr. Semir Nouira
clinical proffesor
Principal Investigators
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Nouira Semir, Pr
Role: PRINCIPAL_INVESTIGATOR
University of Monastir
Locations
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Semir Nouira
Monastir, Monastir Tunisia, Tunisia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Diab-Atherolive
Identifier Type: -
Identifier Source: org_study_id
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