| Trial ID: | L4283 |
| Source ID: | NCT05147896
|
| Associated Drug: |
Semaglutide Oral Tablet
|
| Title: |
Semaglutide Anti-Atherosclerotic Mechanisms of Action Study in Type 2 Diabetes Patients
|
| Acronym: |
SAMAS
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Atherosclerosis
|
| Interventions: |
DRUG: Semaglutide Oral Tablet
|
| Outcome Measures: |
Primary: Change in morphological arterial wall characteristics, Ultrasonographic assessment of cIMT (in millimetres), 1 year|Change in functional arterial wall characteristics, Endothelial function assessment by EndoPAT, 1 year|Change in structural arterial wall characteristics, Arterial stiffness assessment by Sphygmocor device (in meters per second), 1 year | Secondary: Change in atherogenic small dense low-density lipoproteins (sdLDL), Assessment by gel electrophoresis, 1 year|Change in glycated haemoglobin (HbA1c), Assessment by biochemical methods, 1 year|Change in high sensitivity C-reactive protein (hsCRP), Assessment by biochemical methods, 1 year|Correlations between changes in rate of cIMT reduction, % of endothelial function improvement and rate of arterial stiffness reduction on one hand and changes in concentration of sdLDL, % of HbA1c and concentration of hsCRP on the other, Statistical methods, 1 year
|
| Sponsor/Collaborators: |
Sponsor: University Medical Centre Ljubljana | Collaborators: University of Palermo
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-05-01
|
| Completion Date: |
2023-12-01
|
| Results First Posted: |
|
| Last Update Posted: |
2022-05-24
|
| Locations: |
UMC Ljubljana, Diabetes Outpatient Clinic, Ljubljana, Slovenia
|
| URL: |
https://clinicaltrials.gov/show/NCT05147896
|
