Olive Leaf Extracts in the Control of Diabet

NCT05605704 | Recruiting Phase 2

• 1 other identifier: Diab-Atherolive
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes; Atherolive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• variation in lipid balance

  90 days

• rate of hospitalization for cardiovascular disease and adverse effects

  90 days

Study Arms (2)

atherolive

ACTIVE COMPARATOR

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

placebo atherolive

PLACEBO COMPARATOR

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

Drug: Placebo Atherolive

Interventions

Atherolive DRUG

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.

atherolive

Placebo Atherolive DRUG

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.

placebo atherolive

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Semir Nouira

Monastir, Monastir Tunisia, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nouira Semir, Pr

  University of Monastir

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nouira semir, Pr

CONTACT

73106046; semir.nouira@rns.tn

Bel Hadj Ali khaoula, MD

CONTACT

73106046; belhadjalikhaoula@yahoo.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Active Comparator: atherolive group Placebo Comparator: placebo group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical proffesor

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: November 4, 2022
• Study Start: January 1, 2023
• Primary Completion: September 15, 2025
• Study Completion: December 15, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-06

Locations

TU (1)