- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05605704
Olive Leaf Extracts in the Control of Diabet (Dia-Athr)
Efficacy of a Treatment Based on 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
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Nouira Semir, Pr
- Phone Number: 216 73106046
- Email: semir.nouira@rns.tn
Study Contact Backup
- Name: Bel Hadj Ali Khaoula, MD
- Phone Number: 216 73106046
- Email: belhadjalikhaoula@yahoo.fr
Study Locations
-
-
Monastir Tunisia
-
Monastir, Monastir Tunisia, Tunisia, 5000
- Recruiting
- Semir Nouira
-
Contact:
- Semir Nouira
- Phone Number: 73106000
- Email: semir.nouira.urg@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients over 18 years of age with:
- diabetes.
Exclusion Criteria:
- Exclusion criteria: None.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of fasting glycemia level reduction
Time Frame: 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.
|
90 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of H1B1C balance variation
Time Frame: 90 days
|
vatriation in H1B1C balance
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nouira Semir, Pr, University of Monastir
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Diab-Atherolive
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaRecruiting
Clinical Trials on atherolive
-
University of MonastirNot yet recruiting
-
University of MonastirRecruitingHypertension | Diabetes Mellitus, Type 2Tunisia