Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

NCT05857085 · Completed

Last updated 2026-05-28

This clinical trial tests new treatments to improve blood vessel function in adults with type 1 diabetes who have signs of endothelial dysfunction.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 90 people

Who can join Ages 20–70 · all sexes

Timeline Started 2021-12 · est. completion 2023-04

Where 1 site · Slovenia

What this study is testing ClinicalTrials.gov NCT05857085 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide Pen Injector [Ozempic] Drug

GLP 1 agonist
Empagliflozin 10 MG Drug

SGLT 2 inhibitor

Main thing measured	evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery
Sponsor	General and Teaching Hospital Celje
Conditions studied	Endothelial Dysfunction, Diabetes Mellitus, Type 1, Biomarkers, Endothelial Progenitor Cells, SGLT 2 Inhibitors, Incretins, Glucose Excursions, FMD, FPF, Arterial Stiffness
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05857085 ↗