Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated cardiovascular and renal protection in patients with type 2 diabetes (T2D); however, the underlying mechanism remains unclear. We hypothesized that SGLT2 inhibitor will improve the ketone metabolism compared to dipeptidyl Peptidase-4 (DPP4) inhibitor. And we will also evaluate the association between ketone metabolism and cardiac remodeling evaluated by echocardiography. We will randomly assign 122 people with T2DM to receive dapagliflozin 10mg or gemigliptin 50mg. The primary endpoint are changes in acetoacetate, total ketone, beta-hydroxybutyric acid, left ventricular (LV) mass index, and LV global longitudinal strain during 6 months follow-up. This study may provide robust evidence of the thrifty substrate hypothesis for cardiovascular protection of SGLT2 inhibitors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.
The patients assigned to the Gemigliptin group will take Zemiglo Pill 50mg for 6 months.
Yonsei University Wonju College of Medicine
Wŏnju, Gangwondo, South Korea
RECRUITINGChange (%) in acetoacetate, total ketone, beta-hydroxybutyric acid
The change of acetoacetate, total ketone, beta-hydroxybutyric acid from baseline to 6 months follow-up
Time frame: 6 months
Change (%) in LV mass index
The change of LV mass index from baseline to 6 months follow-up
Time frame: 6 months
Change (%) in LV ejection global longitudinal strain
The change of LV mass ejection global longitudinal strain from baseline to 6 months follow-up
Time frame: 6 months
Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure
The change of mean 24hr ambulatory systolic and diastolic blood pressurefrom baseline to 6 months follow-up
Time frame: 6 months
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