Remodeling, Ventricular, Type2 Diabetes
Conditions
Brief summary
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.
Interventions
DRUGDapagliflozin
The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.
DRUGGemigliptin
The patients assigned to the Gemigliptin group will take Zemiglo Pill 50mg for 6 months.
Sponsors
Wonju Severance Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects diagnosed with T2D on stable antidiabetic medication * No recent use of SGLT2 inhibitor within 3 months
Exclusion criteria
* HbA1c \> 10% * Pregnancy or breast feeding * estimated GFR \<45 30 mL/min/1.73㎡ * insulin user
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid | 6 months | The change of acetoacetate, total ketone, beta-hydroxybutyric acid from baseline to 6 months follow-up |
| Change (%) in LV mass index | 6 months | The change of LV mass index from baseline to 6 months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change (%) in LV ejection global longitudinal strain | 6 months | The change of LV mass ejection global longitudinal strain from baseline to 6 months follow-up |
| Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure | 6 months | The change of mean 24hr ambulatory systolic and diastolic blood pressurefrom baseline to 6 months follow-up |
Countries
South Korea
Contacts
Primary ContactDong-Hyuk Cho, MD,PhD
Outcome results
None listed