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Recruiting

NCT Number: NCT05605704

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Semir Nouira

Monastir, Monastir Tunisia, 5000, Tunisia

Location status: Recruiting

Location contact

Semir Nouira

CONTACT

[email protected]

73106000

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Exclusion criteria: None.

Treatment and study plan

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.

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.

Primary outcomes

  1. rate of continuous glycemic monitoring and Hemoglobin A1C

    Time frame: 90 days

    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.

Secondary outcomes

  1. variation in lipid balance

    Time frame: 90 days

    Rate of variation in lipid balance

  2. rate of hospitalization for cardiovascular disease and adverse effects

    Time frame: 90 days

    , rate of hospitalization for cardiovascular disease : acute infarction, hypertension, acute stroke as well as number of adeverse events reported

Study contacts

Contact information is provided by the study sponsor or research team.

Bel Hadj Ali khaoula, MD

CONTACT

[email protected]

73106046 ext. 216

Nouira semir, Pr

CONTACT

[email protected]

73106046 ext. 216

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Acronym: Dia-Athr

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2022
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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