Olive Leaf Extracts in the Control of Diabet

Diabetes Mellitus, Type 2 Clinical Trial

— Dia-Athr  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605704
• Other study ID #: Diab-Atherolive
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2023
• Est. completion date: April 15, 2023

Study information

• Verified date: March 2023
• Source: University of Monastir
• Contact: Nouira semir, Pr
• Phone: 73106046
• Email: semir.nouira[@]rns.tn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients over 18 years of age with:

• diabetes.

Exclusion Criteria:

• Exclusion criteria: None.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Semir Nouira	Monastir	Monastir Tunisia

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rate of H1B1C balance variation	vatriation in H1B1C balance	90 days
Primary	rate of fasting glycemia level reduction	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.	90 days