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Clinical Trial Details

Trial ID: L5611
Source ID: NCT05857085
Associated Drug: Semaglutide Pen Injector [Ozempic]
Title: Novel Therapeutics and Endothelial Dysfunction in T1DM Patients
Acronym: ENDIS
Status: COMPLETED
Study Results: NO
Results:
Conditions: Endothelial Dysfunction|Diabetes Mellitus, Type 1|Biomarkers|Endothelial Progenitor Cells|SGLT 2 Inhibitors|Incretins|Glucose Excursions|FMD|FPF|Arterial Stiffness
Interventions: DRUG: Semaglutide Pen Injector [Ozempic]|DRUG: Empagliflozin 10 MG
Outcome Measures: Primary: evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery, measurement of dilation of brachial artery (in %) before and after postishemic hyperemia comparing two therapeutic groups and control group before and after intervention, 12 weeks|evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow, changes in tissue perfusion (ml/100 ml of tissue/min) measured with strange gauge plethysmography as formarm blood flow before and after postishemic reactive hyperemija comparing two therapeutic groups and control group before and after intervention, 12 weeks|evaluation of arterial stiffness with peak wave velocity ( PWV), measurements of the velocity (m/s) at which arterial blood pressure pulses propagate - comparing two therapeutic groups and control group before and after intervention, 12 weeks | Secondary: evaluation of change in inflammatory biomarkers, change of hs CRF, Il6 after treatment comparing two therapeutic groups and control, 12 weeks|evaluation of change in biomarkers of endothelial dysfunction, change in s-VCAM, s-ICAM values before and after intervention - comparing two therapeutic groups and control, 12 weeks|evaluation of endothelial progenitor cells EPC count, change in count of endothelial progenitor cells CD 34\*, 133+ as endothelial function markers before and after intervention - comparing two therapeutic groups and control, 12 weeks | Other: body impedance measurements, changes in measurements of body composition fat , muscle and water before and after intervention - comparing two therapeutic groups and control, 12 weeks|changes of glycemia endpoints glucovariability/time in range, variability of excursions of glucose - coeficient of variability / time in range defined as blood glucose beetwen 3,9 and 10 mmol/l before and after drug intervention assesed with CGM system, 2 weeks
Sponsor/Collaborators: Sponsor: General and Teaching Hospital Celje
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 90
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-12-15
Completion Date: 2023-04-20
Results First Posted:
Last Update Posted: 2023-05-12
Locations: General Hospital Celje, Celje, 3000, Slovenia
URL: https://clinicaltrials.gov/show/NCT05857085