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ENDIS: Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

Sponsor
General and Teaching Hospital Celje (Other)
Overall Status
Completed
CT.gov ID
NCT05857085
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
16.1
Actual Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Semaglutide Pen Injector [Ozempic]
  • Drug: Empagliflozin 10 MG
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Additional Treatment With Empagliflozin or Semaglutide on Endothelial Function and Other Clinical Parameters and Biomarkers in T1DM Patients
Actual Study Start Date :
Dec 15, 2021
Actual Primary Completion Date :
Mar 10, 2022
Actual Study Completion Date :
Apr 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: GLP 1 agonist

semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII)

Drug: Semaglutide Pen Injector [Ozempic]
GLP 1 agonist
Active Comparator: SGLT 2 inhibitor

empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system)

Drug: Empagliflozin 10 MG
SGLT 2 inhibitor
No Intervention: comparator

continuing treatment only with insulin sheme (MDI or CII or hybride system)

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  1. evaluation of change in inflammatory biomarkers [12 weeks]

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

  2. 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

  3. 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

Other Outcome Measures

  1. body impedance measurements [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 General Hospital Celje Celje Slovenia 3000

Sponsors and Collaborators

  • General and Teaching Hospital Celje

Investigators

  • Study Chair: Andrej Janez, prof PhD, General and teaching hospital Celje and UKC Ljubljana/Maribor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
General and Teaching Hospital Celje
ClinicalTrials.gov Identifier:
NCT05857085
Other Study ID Numbers:
  • 0120-63-2020
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Empagliflozin

Study Results

No Results Posted as of May 12, 2023