Impact of Additional Treatment With Empagliflozin or Semaglutide on Endothelial Function and Other Clinical Parameters and Biomarkers in T1DM Patients
Overview
- Phase
- Phase 4
- Intervention
- Semaglutide Pen Injector [Ozempic]
- Conditions
- Endothelial Dysfunction
- Sponsor
- General and Teaching Hospital Celje
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of study is impact of additional treatment with new antidiabetic drugs (semaglutide or empagliflozine) compared to control group in T1DM patients - impact on endothelial function measured by FMD and FPF, arterial stiffness - measured by PWV, inflammatory biomarkers, markers of oxidative stress and endothelial progenitor cells (CD 34+/VDRL2, CD 133+/VDRL2) and correlation with glucovariability or time in range, measured with CGM system.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HbA1C\<=9%
- •prone to CGM system
- •20 - 70 years
Exclusion Criteria
- •HbA1C \>9%,
- •pregnancy or lactation,
- •known hypersensitivity to study drug,
- •malignant disease ( excluded \>5 years disease free, bazocellular or planocellular ca of skin),
- •liver cirrhosis child C,
- •eGFR\<60 ml/min,
- •chronic inflammatory disease,
- •proliferative diabetic rethinopathy,
- •MEN or medullary thyroid cancer in familly,
- •concomitant drugs with influence on glycemia and antiinflammatory influence (corticosteroids, immunosupresive therapy),
Arms & Interventions
GLP 1 agonist
semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII)
Intervention: Semaglutide Pen Injector [Ozempic]
SGLT 2 inhibitor
empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system)
Intervention: Empagliflozin 10 MG
Outcomes
Primary Outcomes
evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery
Time Frame: 12 weeks
measurement of dilation of brachial artery (in %) before and after postishemic hyperemia comparing two therapeutic groups and control group before and after intervention
evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow
Time Frame: 12 weeks
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
evaluation of arterial stiffness with peak wave velocity ( PWV)
Time Frame: 12 weeks
measurements of the velocity (m/s) at which arterial blood pressure pulses propagate - comparing two therapeutic groups and control group before and after intervention
Secondary Outcomes
- evaluation of change in inflammatory biomarkers(12 weeks)
- evaluation of change in biomarkers of endothelial dysfunction(12 weeks)
- evaluation of endothelial progenitor cells EPC count(12 weeks)