Olive Leaf Extracts in the Control of Diabet (Dia-Athr)

University of Monastir

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Atherolive; Drug: Placebo Atherolive

Study type: Interventional

Funder types: Other

Identifiers

NCT05605704

Diab-Atherolive

Details and patient eligibility

About

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

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age with:
• diabetes.

Exclusion criteria

• Exclusion criteria: None.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups, including a placebo group

atherolive

Active Comparator group

Description:

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.

Treatment:

Drug: Atherolive

placebo atherolive

Placebo Comparator group

Description:

In this Arm patients will receive the placebo at a dose of 400 mg once a day for 3 months.

Treatment:

Drug: Placebo Atherolive