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Novel Therapeutics and Endothelial Dysfunction in T1DM Patients (ENDIS)

Primary Purpose

Endothelial Dysfunction, Diabetes Mellitus, Type 1, Biomarkers

Status
Completed
Phase
Phase 4
Locations
Slovenia
Study Type
Interventional
Intervention
Semaglutide Pen Injector [Ozempic]
Empagliflozin 10 MG
Sponsored by
General and Teaching Hospital Celje
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endothelial Dysfunction

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • General Hospital Celje

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

GLP 1 agonist

SGLT 2 inhibitor

comparator

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

evaluation of change in inflammatory biomarkers
change of hs CRF, Il6 after treatment comparing two therapeutic groups and control
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
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

Full Information

First Posted
September 29, 2020
Last Updated
May 10, 2023
Sponsor
General and Teaching Hospital Celje
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1. Study Identification

Unique Protocol Identification Number
NCT05857085
Brief Title
Novel Therapeutics and Endothelial Dysfunction in T1DM Patients
Acronym
ENDIS
Official Title
Impact of Additional Treatment With Empagliflozin or Semaglutide on Endothelial Function and Other Clinical Parameters and Biomarkers in T1DM Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General and Teaching Hospital Celje

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Diabetes Mellitus, Type 1, Biomarkers, Endothelial Progenitor Cells, SGLT 2 Inhibitors, Incretins, Glucose Excursions, FMD, FPF, Arterial Stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLP 1 agonist
Arm Type
Active Comparator
Arm Description
semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII)
Arm Title
SGLT 2 inhibitor
Arm Type
Active Comparator
Arm Description
empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system)
Arm Title
comparator
Arm Type
No Intervention
Arm Description
continuing treatment only with insulin sheme (MDI or CII or hybride system)
Intervention Type
Drug
Intervention Name(s)
Semaglutide Pen Injector [Ozempic]
Intervention Description
GLP 1 agonist
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Intervention Description
SGLT 2 inhibitor
Primary Outcome Measure Information:
Title
evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery
Description
measurement of dilation of brachial artery (in %) before and after postishemic hyperemia comparing two therapeutic groups and control group before and after intervention
Time Frame
12 weeks
Title
evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow
Description
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
Time Frame
12 weeks
Title
evaluation of arterial stiffness with peak wave velocity ( PWV)
Description
measurements of the velocity (m/s) at which arterial blood pressure pulses propagate - comparing two therapeutic groups and control group before and after intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
evaluation of change in inflammatory biomarkers
Description
change of hs CRF, Il6 after treatment comparing two therapeutic groups and control
Time Frame
12 weeks
Title
evaluation of change in biomarkers of endothelial dysfunction
Description
change in s-VCAM, s-ICAM values before and after intervention - comparing two therapeutic groups and control
Time Frame
12 weeks
Title
evaluation of endothelial progenitor cells EPC count
Description
change in count of endothelial progenitor cells CD 34*, 133+ as endothelial function markers before and after intervention - comparing two therapeutic groups and control
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
body impedance measurements
Description
changes in measurements of body composition fat , muscle and water before and after intervention - comparing two therapeutic groups and control
Time Frame
12 weeks
Title
changes of glycemia endpoints glucovariability/time in range
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Janez, prof PhD
Organizational Affiliation
General and teaching hospital Celje and UKC Ljubljana/Maribor
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital Celje
City
Celje
ZIP/Postal Code
3000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No

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Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

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