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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP 1 agonist | Active Comparator | semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII) |
|
| SGLT 2 inhibitor | Active Comparator | empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system) |
|
| comparator | No Intervention | continuing treatment only with insulin sheme (MDI or CII or hybride system) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide Pen Injector [Ozempic] | Drug | GLP 1 agonist |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrej Janez, prof PhD | General and teaching hospital Celje and UKC Ljubljana/Maribor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Celje | Celje | 3000 | Slovenia |
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2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients
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| Empagliflozin 10 MG |
| Drug |
SGLT 2 inhibitor |
|
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 |
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 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| C570240 | empagliflozin |
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