Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1; Biomarkers; Endothelial Progenitor Cells; Incretins; Arterial Stiffness; Endothelial Dysfunction; FPF; SGLT 2 Inhibitors; FMD; Glucose Excursions
• Interventions: Drug: Semaglutide Pen Injector [Ozempic]; Drug: Empagliflozin 10 MG

• Registration Number: NCT05857085
• Lead Sponsor: General and Teaching Hospital Celje

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-29
• Study Start: 2021-12-15
• Primary Completion: 2022-03-10
• Study Completion: 2023-04-20
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLP 1 agonist	Semaglutide Pen Injector [Ozempic]	semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII)
SGLT 2 inhibitor	Empagliflozin 10 MG	empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system)

Primary Outcome Measures

Name	Time	Method
evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery	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
evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow	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
evaluation of arterial stiffness with peak wave velocity ( PWV)	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 Outcome Measures

Name	Time	Method
evaluation of change in inflammatory biomarkers	12 weeks	change of hs CRF, Il6 after treatment comparing two therapeutic groups and control
evaluation of change in biomarkers of endothelial dysfunction	12 weeks	change in s-VCAM, s-ICAM values before and after intervention - comparing two therapeutic groups and control
evaluation of endothelial progenitor cells EPC count	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

Trial Locations

Locations (1)

General Hospital Celje; 🇸🇮 Celje, Slovenia