Diabetes Mellitus, Type 2Phase 2/3Dia-AthrNCT05605704
Olive Leaf Extracts in the Control of Diabet
A Phase 2/3 study testing Atherolive in people with Diabetes Mellitus, Type 2, run by University of Monastir at 1 site in Tunisia.
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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Atherolive
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2023to 15 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age with:
- diabetes.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Semir Nouira
Monastir, Monastir Tunisia, 5000
Semir Nouira, 73106000, semir.nouira.urg@gmail.com
About this study
Official title: 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
Read the 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
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Atherolive, Placebo Atherolive
- Keywords
- diabetes, Atherolive
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtheroliveDrug
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 AtheroliveDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| atherolive | Active comparator | In this Arm the patient will receive the study drug (atherol) that will be prescribed at a dose of 400 mg, once a day for 3 months. Receives: Drug: Atherolive |
| placebo atherolive | Placebo comparator | In this Arm patients will receive the placebo at a dose of 400 mg once a day for 3 months. Receives: Drug: Placebo Atherolive |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of continuous glycemic monitoring and Hemoglobin A1C
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.
Measured: 90 days
Secondary outcomes (2)
variation in lipid balance
Rate of variation in lipid balance
Measured: 90 days
rate of hospitalization for cardiovascular disease and adverse effects
, rate of hospitalization for cardiovascular disease : acute infarction, hypertension, acute stroke as well as number of adeverse events reported
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Jan 2023
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Semir, Pr, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605704
- Sponsor's protocol ID
- Diab-Atherolive
- Acronym
- Dia-Athr
- Status last verified
- Jun 2025
- First submitted
- 22 Sep 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Diabet
- ClinicalTrials.gov ID
- NCT05605704
- Acronym / sponsor ID
- Dia-Athr / Diab-Atherolive
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, Atherolive
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| atherolive | Active comparator | Drug: AtheroliveIn this Arm the patient will receive the study drug (atherol) that will be prescribed at a dose of 400 mg, once a day for 3 months. |
| placebo atherolive | Placebo comparator | Drug: Placebo AtheroliveIn this Arm patients will receive the placebo at a dose of 400 mg once a day for 3 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age with:
- diabetes.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtheroliveThe 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. | Drug | atherolive |
| Placebo AtheroliveThe 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. | Drug | placebo atherolive |
Primary outcome
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.
2 secondary outcomes
variation in lipid balance
Time frame: 90 days
rate of hospitalization for cardiovascular disease and adverse effects
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nouira Semir, Pr principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atherolive in people with Diabetes Mellitus, Type 2, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nouira semir, Pr (73106046 ext. 216, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of continuous glycemic monitoring and Hemoglobin A1C (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.