Olive Leaf Extracts in the Control of Diabet
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atherolive, Placebo Atherolive.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Tunisia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Diabet
Overview
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: -Diabets
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 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
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- rate of continuous glycemic monitoring and Hemoglobin A1C [Time frame: 90 days]
Secondary outcome measures (2)
- variation in lipid balance [Time frame: 90 days]
- rate of hospitalization for cardiovascular disease and adverse effects [Time frame: 90 days]
Eligibility criteria
Inclusion criteria
- Patients over 18 years of age with:
- diabetes.
Exclusion criteria
- Exclusion criteria: None.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Tunisia · 1 center
- Semir Nouira — Monastir
Identifiers
NCT: NCT05605704 · Diab-Atherolive