Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

Diabetes Mellitus, Type 1 Clinical Trial

— ENDIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05857085
• Other study ID #: 0120-63-2020
• Status: Completed
• Phase: Phase 4
• Start date: December 15, 2021
• Est. completion date: April 20, 2023

Study information

• Verified date: May 2023
• Source: General and Teaching Hospital Celje
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 20, 2023
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arterial Stiffness
• Biomarkers
• Diabetes Mellitus, Type 1
• Endothelial Dysfunction
• Endothelial Progenitor Cells
• FMD
• Incretins

Intervention

Drug:
• Semaglutide Pen Injector [Ozempic]
GLP 1 agonist
• Empagliflozin 10 MG
SGLT 2 inhibitor

Locations

Country	Name	City	State
Slovenia	General Hospital Celje	Celje

Sponsors (1)

Lead Sponsor	Collaborator
General and Teaching Hospital Celje

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	body impedance measurements	changes in measurements of body composition fat , muscle and water before and after intervention - comparing two therapeutic groups and control	12 weeks
Other	changes of glycemia endpoints glucovariability/time in range	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	2 weeks
Primary	evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery	measurement of dilation of brachial artery (in %) before and after postishemic hyperemia comparing two therapeutic groups and control group before and after intervention	12 weeks
Primary	evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow	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	12 weeks
Primary	evaluation of arterial stiffness with peak wave velocity ( PWV)	measurements of the velocity (m/s) at which arterial blood pressure pulses propagate - comparing two therapeutic groups and control group before and after intervention	12 weeks
Secondary	evaluation of change in inflammatory biomarkers	change of hs CRF, Il6 after treatment comparing two therapeutic groups and control	12 weeks
Secondary	evaluation of change in biomarkers of endothelial dysfunction	change in s-VCAM, s-ICAM values before and after intervention - comparing two therapeutic groups and control	12 weeks
Secondary	evaluation of endothelial progenitor cells EPC count	change in count of endothelial progenitor cells CD 34*, 133+ as endothelial function markers before and after intervention - comparing two therapeutic groups and control	12 weeks