Health TrialsbyHealthPanel

Olive Leaf Extracts in the Control of Diabet

ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Monastir

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diabetes.

Disqualifiers

Exclusion criteria: None.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atherolive

    Drug

    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 Atherolive

    Drug

    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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: atheroliveActive comparator 1 intervention
Group B: placebo atherolivePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
90 days

Secondary outcomes

1

variation in lipid balance

Rate of variation in lipid balance

Time frame
90 days
2

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

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Monastir

Lead sponsor

Source ClinicalTrials.gov
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