Arterial Stiffness, Biomarkers, Diabetes Mellitus, Type 1, Endothelial Dysfunction, Endothelial Progenitor Cells, FMD, FPF, Glucose Excursions, Incretins, SGLT 2 Inhibitors
Conditions
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.
Interventions
GLP 1 agonist
DRUGEmpagliflozin 10 MG
SGLT 2 inhibitor
Sponsors
General and Teaching Hospital Celje
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* T1DM * HbA1C\<=9% * prone to CGM system * 20 - 70 years
Exclusion criteria
* HbA1C \>9%, * BMI\<22, * 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), * Major cardiovascular event last 2 months ( stroke, MI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of arterial stiffness with peak wave velocity ( PWV) | 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 |
| evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow | 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 endothelial function by flow mediated dilation (FMD) of brachial artery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of endothelial progenitor cells EPC count | 12 weeks | change in count of endothelial progenitor cells CD 34\*, 133+ as endothelial function markers before and after intervention - comparing two therapeutic groups and control |
| evaluation of change in inflammatory biomarkers | 12 weeks | change of hs CRF, Il6 after treatment comparing two therapeutic groups and control |
| evaluation of change in biomarkers of endothelial dysfunction | 12 weeks | change in s-VCAM, s-ICAM values before and after intervention - comparing two therapeutic groups and control |
Other
| Measure | Time frame | Description |
|---|---|---|
| body impedance measurements | 12 weeks | changes in measurements of body composition fat , muscle and water before and after intervention - comparing two therapeutic groups and control |
| changes of glycemia endpoints glucovariability/time in range | 2 weeks | 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 |
Countries
Slovenia
Outcome results
None listed