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Clinical Trial Details

Trial ID: L1899
Source ID: NCT06301191
Associated Drug: Semaglutide, 1.0 Mg/Ml
Title: The Effect of Semaglutide on Cardiovascular Markers and Liver Function
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Type 2
Interventions: DRUG: Semaglutide, 1.0 mg/mL|DRUG: Dipeptidyl Peptidase 4 inhibitor
Outcome Measures: Primary: Comparison of arterial stiffness markers difference among treatment groups, Comparison of pulse wave velocity difference among treatment groups. Two non-invasive pressure sensors will be used to record the carotid and femoral waveforms and the distance between the two arterial sites will be measured with a tape measure. Pulse wave velocity is calculated as the distance divided by transit time between waves (m/s)., 12 months|Comparison of endothelial glycocalyx thickness difference among treatment groups, The investigators will measure the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield imaging that provides a direct, noninvasive, and fast method for the assessment of the endothelial glycocalyx. The PBR is the cell-poor layer which results from the phase separation between the flowing red blood cells (RBC) and plasma on the surface of the microvessel lumen. The PBR includes the most luminal part of glycocalyx that does allow cell penetration. Thus, an increased perfused boundary region is consistent with deeper penetration of erythrocytes into glycocalyx, indicating a loss of glycocalyx barrier properties and is a marker of reduced glycocalyx thickness., 12 months|Comparison of liver stiffness difference among treatment groups, CAP score will be used as an index of liver fat content, with normal values being \< 238 dB/m. \<237 dB/m (S0, no steatosis), 237 -259 dB/m (S1, mild steatosis), 259 -291 dB/m (S2, moderate steatosis), and 291 -400 dB/m (S3,severe steatosis). E score will be used as an index of liver fibrosis. The cut-off values for fibrosis (F) were as follows:(1) \<5.5 kPa (F0, no fibrosis), (2) 5.5-8.0 kPa (F1, mild fibrosis), (3) 8.0-10.0 kPa (F2, moderate fibrosis),(4) 11.0-16.0 kPa (F3, severe fibrosis), and (5) \>16.0 kPa (F4, cirrhosis)., 12 months |
Sponsor/Collaborators: Sponsor: Attikon Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 50
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-03-01
Completion Date: 2024-05-01
Results First Posted:
Last Update Posted: 2024-03-08
Locations: Attikon University General Hospital, Athens, 12462, Greece
URL: https://clinicaltrials.gov/show/NCT06301191