Dia-Athr: Olive Leaf Extracts in the Control of Diabet

Sponsor

University of Monastir (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05605704

Collaborator

(none)

500

Enrollment

Arms

3.4

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: atherolive	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Masking Description:

Active Comparator: atherolive group Placebo Comparator: placebo group

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Apr 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: atherolive In each study population(Diabetic), 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.
Placebo Comparator: placebo 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.	Drug: atherolive In each study population(Diabetic), 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.

Arm

Intervention/Treatment

Active Comparator: atherolive

Drug: atherolive

In each study population(Diabetic), 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.

Placebo Comparator: placebo atherolive

Drug: atherolive

Outcome Measures

Primary Outcome Measures

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.

Other Outcome Measures

rate of H1B1C balance variation [90 days]
vatriation in H1B1C balance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients over 18 years of age with:
diabetes.

Exclusion Criteria:

Exclusion criteria: None.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Monastir

Investigators

Principal Investigator: Nouira Semir, Pr, University of Monastir

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pr. Semir Nouira, clinical proffesor, University of Monastir

ClinicalTrials.gov Identifier:

NCT05605704

Other Study ID Numbers:

Diab-Atherolive

First Posted:

Nov 4, 2022

Last Update Posted:

Jan 10, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pr. Semir Nouira, clinical proffesor, University of Monastir

diabetes

Atherolive

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 10, 2023