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Clinical Trial Details

Trial ID: L3050
Source ID: NCT05303857
Associated Drug: Semaglutide Pen Injector
Title: Analyse the Effect of Semaglutide on Vascular Structure and Function in Patients With Early Type 2 Diabetes
Acronym: SEMA
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide Pen Injector|DRUG: Placebo
Outcome Measures: Primary: Central (aortic) pulse pressure assessed by Sphygmocor XCEL, The primary objective of the study is to analyze the effect of semaglutide, compared to placebo, on: central (aortic) pulse pressure after 16 weeks of treatment from baseline, 16 weeks | Secondary: Central (aortic) systolic pressure assessed by Sphygmocor XCEL, change of central (aortic) systolic pressure after 16 weeks of treatment from baseline, 16 weeks|Augmentation pressure assessed by Sphygmocor XCEL, change of augmentation pressure after 16 weeks of treatment from baseline, 16 weeks|Augmentation index (cAIX@75) assessed by Sphygmocor XCEL, change of augmentation index (cAIX@75) after 16 weeks of treatment from baseline, 16 weeks|Forward wave amplitude assessed by Sphygmocor XCEL, change of forward wave amplitude after 16 weeks of treatment from baseline, 16 weeks|Backward wave amplitude assessed by Sphygmocor XCEL, change of backward wave amplitude after 16 weeks of treatment from baseline, 16 weeks|Outer diameter of small retinal arterioles assessed by Scanning laser Doppler flowmetry, change of outer diameter of small retinal arterioles after 16 weeks of treatment from baseline, 16 weeks|Inner diameter of small retinal arterioles assessed by Scanning laser Doppler flowmetry, change of inner diameter of small retinal arterioles after 16 weeks of treatment from baseline, 16 weeks|Wall to lumen ratio of small retinal arterioles assessed by Scanning laser Doppler flowmetry, change of wall to lumen ratio of small retinal arterioles after 16 weeks of treatment from baseline, 16 weeks|Flow-mediated Vasodilation (FMD) of the brachial artery assessed by UNEX EF, change of FMD of the brachial artery after 16 weeks of treatment from baseline, 16 weeks|Pulse wave velocity assessed by Sphygmocor XCEL, change of pulse wave velocity after 16 weeks of treatment from baseline, 16 weeks|24-h ambulatory BP (brachial and central) assessed by Mobil-O-Graph®, change of 24-h ambulatory BP (brachial and central) after 16 weeks of treatment from baseline, 16 weeks|24-h ambulatory vascular parameter assessed by Mobil-O-Graph®, change of 24-h ambulatory vascular parameter (pulse wave velocity) from baseline, 16 weeks|24-h ambulatory vascular parameter assessed by Mobil-O-Graph®, change of 24-h ambulatory vascular parameter (central pulse pressure, central systolic pressure) from baseline, 16 weeks|Renal perfusion of both kidneys assessed by Arterial Spin Labeling MRI, change of renal perfusion (total, cortical, medullary) from baseline, 16 weeks
Sponsor/Collaborators: Sponsor: University of Erlangen-Nürnberg Medical School
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 90
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-03-03
Completion Date: 2024-12
Results First Posted:
Last Update Posted: 2024-11-05
Locations: Clinical Research Center, Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, 91054, Germany
URL: https://clinicaltrials.gov/show/NCT05303857