Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

Sponsor
General and Teaching Hospital Celje
Study ID
NCT05857085
Phase
PHASE4
Status
Completed

Conditions

  • Arterial Stiffness
  • Biomarkers
  • Diabetes Mellitus, Type 1
  • Endothelial Dysfunction
  • Endothelial Progenitor Cells
  • FMD
  • FPF
  • Glucose Excursions
  • Incretins
  • SGLT 2 Inhibitors

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 15, 2021
Status verified
May 2023
Primary completion
Mar 10, 2022
Completion
Apr 20, 2023

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: GLP 1 agonist
    semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII)
  • Active Comparator: SGLT 2 inhibitor
    empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system)
  • No Intervention: comparator
    continuing treatment only with insulin sheme (MDI or CII or hybride system)

Primary Outcome Measure

evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery [ Time Frame: 12 weeks ]

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