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

Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Diabet

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Atherolive; Drug: Placebo Atherolive

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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Nouira semir, Pr; Phone Number: 216 73106046; Email: semir.nouira@rns.tn
• Study Contact Backup: Name: Bel Hadj Ali khaoula, MD; Phone Number: 216 73106046; Email: belhadjalikhaoula@yahoo.fr

Study Locations

• Tunisia
  • Monastir Tunisia
    • Monastir, Monastir Tunisia, Tunisia, 5000
      • Recruiting
      • Semir Nouira
      • Contact: Semir Nouira; Phone Number: 73106000; Email: semir.nouira.urg@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Exclusion criteria: None.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Placebo Comparator: placebo atherolive; In this Arm patients will receive the placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of continuous glycemic monitoring and Hemoglobin A1C	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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variation in lipid balance	Rate of variation in lipid balance	90 days
rate of hospitalization for cardiovascular disease and adverse effects	, rate of hospitalization for cardiovascular disease : acute infarction, hypertension, acute stroke as well as number of adeverse events reported	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of H1B1C balance variation	vatriation in H1B1C balance	90 days

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Nouira Semir, Pr, University of Monastir

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: October 29, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; Atherolive
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Diab-Atherolive

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No