The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination
ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-80
SponsorUniversity of Athens
About this trial
A. Four groups of patients with type 2 diabetes mellitus with high or very high cardiovascular risk or heart failure with preserved ejection fraction (HFpEF) will be studied before and at 6 and 12 months of treatment:
* 60 patients treated with a combination of GLP1 analogue and SGLT2 inhibitor ± metformin * 60 patients treated with GLP-1 agonist as a second step after metformin * 60 patients treated with SGLT2 inhibitor as a second step after metformin * 60 patients treated with a combination of insulin and other antidiabetic agents (metformin - DPP4 inhibitors) 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject has type 2 diabetes mellitus
Subject has high or very high cardiovascular risk
Subject has heart failure with preserved ejection fraction
Disqualifiers
Subject has type 1 diabetes mellitus
Subject has kidney disease
Subject has retinopathy
Trial population
240 individuals (60 subjects in each group)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
240 Participants
are grouped into 4 trial groupsGroup A: GLP1 and SGLT2i group
Group B: GLP1 group
Group C: SGLT2i group
Group D: Control group
Trial outcomes
Primary outcomes
1
Comparison of Global Longitudinal Strain (GLS) difference among treatment groups.
Comparison of Global Longitudinal Strain (GLS) difference among treatment groups, measured by echocardiographic study
Time frame
12 monthsSecondary outcomes
1
Comparison of arterial stiffness markers difference among treatment groups.
Comparison of pulse wave velocity difference among treatment groups
Time frame
12 months2
Comparison of wave reflection markers difference among treatment groups
Comparison of central augmentation index (Aix%) difference among treatment groups
Time frame
12 months3
Comparison of central aortic blood pressure differences among treatment groups
Comparison of both central systolic and diastolic aortic blood pressure differences among treatment groups
Time frame
12 months4
Comparison of endothelial glycocalyx thickness difference among treatment groups
Comparison of Perfused Boundary Region (PBR) difference of sublingual vessels among treatment groups
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov