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Completed

NCT Number: NCT05857085

Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

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.

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Key information

Conditions

Endothelial Dysfunction Arterial Stiffness Autoimmune Diseases Biomarkers Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Endothelial Progenitor Cells FMD FPF Glucose Excursions Glucose Metabolism Disorders Immune System Diseases Incretins Metabolic Diseases Nutritional and Metabolic Diseases SGLT 2 Inhibitors

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital Celje

Celje, 3000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Semaglutide Pen Injector [Ozempic]

Drug

GLP 1 agonist

Empagliflozin 10 MG

Drug

SGLT 2 inhibitor

Primary outcomes

  1. evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery

    Time frame: 12 weeks

    measurement of dilation of brachial artery (in %) before and after postishemic hyperemia comparing two therapeutic groups and control group before and after intervention

  2. evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow

    Time frame: 12 weeks

    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

  3. evaluation of arterial stiffness with peak wave velocity ( PWV)

    Time frame: 12 weeks

    measurements of the velocity (m/s) at which arterial blood pressure pulses propagate - comparing two therapeutic groups and control group before and after intervention

Secondary outcomes

  1. evaluation of change in inflammatory biomarkers

    Time frame: 12 weeks

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

  2. evaluation of change in biomarkers of endothelial dysfunction

    Time frame: 12 weeks

    change in s-VCAM, s-ICAM values before and after intervention - comparing two therapeutic groups and control

  3. evaluation of endothelial progenitor cells EPC count

    Time frame: 12 weeks

    change in count of endothelial progenitor cells CD 34*, 133+ as endothelial function markers before and after intervention - comparing two therapeutic groups and control

Other outcomes

  1. body impedance measurements

    Time frame: 12 weeks

    changes in measurements of body composition fat , muscle and water before and after intervention - comparing two therapeutic groups and control

  2. changes of glycemia endpoints glucovariability/time in range

    Time frame: 2 weeks

    variability of excursions of glucose - coeficient of variability / time in range defined as blood glucose beetwen 3,9 and 10 mmol/l before and after drug intervention assesed with CGM system

Sponsors and collaborators

Lead sponsor

General and Teaching Hospital Celje

Other

Registry information

Official study title

Impact of Additional Treatment With Empagliflozin or Semaglutide on Endothelial Function and Other Clinical Parameters and Biomarkers in T1DM Patients

Acronym: ENDIS

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 12, 2023
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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