Olive Leaf Extracts in the Control of Diabet

Phase 2

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: atherolive

• Registration Number: NCT05605704
• Lead Sponsor: University of Monastir

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:

-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

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-10-29
• Study First Posted: 2022-11-04
• Study Start: 2023-01-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14
• Primary Completion: 2023-03-15
• Study Completion: 2023-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

• Exclusion criteria: None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo atherolive	atherolive	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.
atherolive	atherolive	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.

Primary Outcome Measures

Name	Time	Method
rate of fasting glycemia level reduction	90 days	morning glycemic cycle:These patients will be fitted with an iPro continuous glycemic monitoring (CGM) recorder (Medtronic, Northridge, CA) for 24 consecutive hours on an outpatient basis . A CGM (Enlite Sensor) sensor is inserted into abdominal (or arm) fatty tissue subcutaneously and calibrated according to Medtronic standard operating guidelines. The iPro Continuous Glucose Recorder measures interstitial subcutaneous tissue glucose levels continuously, recording values every 5 minutes, over a range of 40-400 mg/dL.recorded data will be downloaded for analysis of glucose profile and glucose excursion parameters with the CareLink iPro system. Analysis will be performed on the data obtained within the 24-hour period after placement.

Trial Locations

Locations (1)

Semir Nouira; 🇹🇳 Monastir, Monastir Tunisia, Tunisia