Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

General and Teaching Hospital Celje90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endothelial Dysfunction Diabetes Mellitus, Type 1 Biomarkers Endothelial Progenitor Cells SGLT 2 Inhibitors

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Secondary Outcomes

evaluation of change in inflammatory biomarkers

change of hs CRF, Il6 after treatment comparing two therapeutic groups and control

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes