Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

• Status: Completed
• Trial end date: 2023-04-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: General and Teaching Hospital Celje
• Treatments: Empagliflozin

Criteria

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)