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The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03878706
Recruitment Status : Unknown
Verified March 2019 by Ignatios Ikonomidis, University of Athens.
Recruitment status was:  Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

Brief Summary:

A. Four groups of patients with type 2 diabetes mellitus with high cardiovascular risk will be studied before and after 3 months of treatment:

  • 40 patients treated with a combination of GLP1 analogue and SGLT2 inhibitor ± metformin
  • 40 patients treated with GLP-1 agonist as a second step after metformin
  • 40 patients treated with SGLT2 inhibitor as a second step after metformin
  • 40 patients treated with a combination of insulin and other antidiabetic agents (metformin - DPP4inhibitors) Individuals will be equal distributed as far as age, gender and body mass index concerned. In addition, patients suffered from kidney disease and retinopathy are excluded.

Condition or disease
Diabetes Mellitus, Type 2

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Distortion in Patients With Type 2 Diabetes With High Cardiovascular Risk
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
GLP1 and SGLT2i group
40 patients treated with a combination of liraglutide and empagliflozin.All subjects will be submitted to an echocardiographic study in order to estimate the GLS as well as the twisting-untwisting of the left ventricle using speckle tracking imaging. PWV, AIx,SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of subglottic vessels using a high-resolution special lens with Sideview Darkfield Imaging technique (Microscan, Glucockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx.Oxidation load markers, blood glucose, glycosylated hemoglobin HbA1c and a full lipidemic profile will be measured before and after 3 months of treatment.
GLP1 group
40 patients treated with liraglutide.All subjects will be submitted to an echocardiographic study in order to estimate the GLS as well as the twisting-untwisting of the left ventricle using speckle tracking imaging. PWV, AIx,SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of subglottic vessels using a high-resolution special lens with Sideview Darkfield Imaging technique (Microscan, Glucockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx.Oxidation load markers, blood glucose, glycosylated hemoglobin HbA1c and a full lipidemic profile will be measured before and after 3 months of treatment.
SGLT2i group
40 patients treated with empagliflozin.All subjects will be submitted to an echocardiographic study in order to estimate the GLS as well as the twisting-untwisting of the left ventricle using speckle tracking imaging. PWV, AIx,SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of subglottic vessels using a high-resolution special lens with Sideview Darkfield Imaging technique (Microscan, Glucockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx.Oxidation load markers, blood glucose, glycosylated hemoglobin HbA1c and a full lipidemic profile will be measured before and after 3 months of treatment.
Control group
40 patients treated with insulin and metformin.All subjects will be submitted to an echocardiographic study in order to estimate the GLS as well as the twisting-untwisting of the left ventricle using speckle tracking imaging. PWV, AIx,SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of subglottic vessels using a high-resolution special lens with Sideview Darkfield Imaging technique (Microscan, Glucockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx.Oxidation load markers, blood glucose, glycosylated hemoglobin HbA1c and a full lipidemic profile will be measured before and after 3 months of treatment.



Primary Outcome Measures :
  1. Comparison of Global Longitudinal Strain (GLS) difference among treatment groups. [ Time Frame: 12 months ]
    Comparison of Global Longitudinal Strain (GLS) difference among treatment groups, measured by echocardiographic study


Secondary Outcome Measures :
  1. Comparison of arterial stiffness markers difference among treatment groups. [ Time Frame: 12 months ]
    Comparison of pulse wave velocity difference among treatment groups

  2. Comparison of wave reflection markers difference among treatment groups [ Time Frame: 12 months ]
    Comparison of central augmentation index (Aix%) difference among treatment groups

  3. Comparison of central aortic blood pressure differences among treatment groups [ Time Frame: 12 months ]
    Comparison of both central systolic and diastolic aortic blood pressure differences among treatment groups

  4. Comparison of endothelial glycocalyx thickness difference among treatment groups [ Time Frame: 12 months ]
    Comparison of Perfused Boundary Region(PBR) difference of sublingual vessels among treatment groups

  5. Comparison of oxidative stress biomarkers differences among treatment groups [ Time Frame: 12 months ]
    Comparison of malondialdehyde and protein carbonyls plasma levels among treatment groups


Biospecimen Retention:   Samples Without DNA
Blood sample obtained from the subjects for oxidative stress markers measuring.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
160 individuals (40 subjects in each group)
Criteria

Inclusion Criteria:

  • Subject has type 2 diabetes mellitus
  • Subject has high cardiovascular risk

Exclusion Criteria:

  • Subject has type 1 diabettes mellitus
  • Subject has kidney disease
  • Subject has retinopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878706


Contacts
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Contact: Ignatios Ikonomidis, Prof. 00306944805732 ignoik@gmail.com
Contact: Aimilianos N. Kalogeris, MD 00306949630300 kalogeris.cardio@gmail.com

Locations
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Greece
"Attikon" University General Hospital Recruiting
Athens, Attiki, Greece, 12462
Principal Investigator: Ignatios Ikonomidis, MD         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Ignatios Ikonomidis, Prof 2nd Department of Cardiology, National and Kapodistrian University of Athens
Principal Investigator: Aimilianos N. Kalogeris, MD 2nd Department of Cardiology, University of Athens
Principal Investigator: John A. Thymis, MD 2nd Department of Cardiology,University of Athens
Principal Investigator: Vaia Lambadiari, Prof. National and Kapodistrian University of Athens
Study Chair: Georgios Dimitriadis, Prof. National and Kapodistrian University of Athens
Study Chair: Efstathios Iliodromitis, Prof. National and Kapodistrian University of Athens
Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ignatios Ikonomidis, Associate Professor in Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT03878706    
Other Study ID Numbers: 2790/03-11-2017
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ignatios Ikonomidis, University of Athens:
Endothelial glycocalyx integrity
Oxidative stress biomarkers
Arterial stiffness
GLS
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases