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Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

NCT05857085 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-05-12

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Semaglutide Pen Injector [Ozempic]

GLP 1 agonist

DRUG

Empagliflozin 10 MG

SGLT 2 inhibitor

Sponsors & Collaborators

  • General and Teaching Hospital Celje

    lead OTHER

Principal Investigators

  • Andrej Janez, prof PhD · General and teaching hospital Celje and UKC Ljubljana/Maribor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2022-03-10
Completion
2023-04-20

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857085 on ClinicalTrials.gov