| Trial ID: | L2806 |
| Source ID: | NCT05605704
|
| Associated Drug: |
Atherolive
|
| Title: |
Olive Leaf Extracts in the Control of Diabet
|
| Acronym: |
Dia-Athr
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: atherolive
|
| Outcome Measures: |
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 | Other: rate of H1B1C balance variation, vatriation in H1B1C balance, 90 days
|
| Sponsor/Collaborators: |
Sponsor: University of Monastir
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
500
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
|
| Start Date: |
2023-01-01
|
| Completion Date: |
2023-04-15
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-14
|
| Locations: |
Semir Nouira, Monastir, Monastir Tunisia, 5000, Tunisia
|
| URL: |
https://clinicaltrials.gov/show/NCT05605704
|
