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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 2
Locations
Tunisia
Study Type
Interventional
Intervention
atherolive
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, Atherolive

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients over 18 years of age with: diabetes. Exclusion Criteria: Exclusion criteria: None.

Sites / Locations

  • Semir NouiraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

atherolive

placebo atherolive

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2022
Last Updated
March 13, 2023
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT05605704
Brief Title
Olive Leaf Extracts in the Control of Diabet
Acronym
Dia-Athr
Official Title
Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Diabet
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diabetes, Atherolive

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Active Comparator: atherolive group Placebo Comparator: placebo group
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
atherolive
Arm Type
Active Comparator
Arm 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.
Arm Title
placebo atherolive
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
atherolive
Intervention Description
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.
Primary Outcome Measure Information:
Title
rate of fasting glycemia level reduction
Description
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.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
rate of H1B1C balance variation
Description
vatriation in H1B1C balance
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age with: diabetes. Exclusion Criteria: Exclusion criteria: None.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nouira semir, Pr
Phone
73106046
Ext
216
Email
semir.nouira@rns.tn
First Name & Middle Initial & Last Name or Official Title & Degree
Bel Hadj Ali khaoula, MD
Phone
73106046
Ext
216
Email
belhadjalikhaoula@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Semir, Pr
Organizational Affiliation
University of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semir Nouira
City
Monastir
State/Province
Monastir Tunisia
ZIP/Postal Code
5000
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Semir Nouira
Phone
73106000
Email
semir.nouira.urg@gmail.com

12. IPD Sharing Statement

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Olive Leaf Extracts in the Control of Diabet

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