Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with T2D on stable antidiabetic medication
- •No recent use of SGLT2 inhibitor within 3 months
排除标准
- •HbA1c > 10%
- •Pregnancy or breast feeding
- •estimated GFR <45 30 mL/min/1.73㎡
- •insulin user
研究组 & 干预措施
Dapagliflozin group
Dapagliflozin 10mg for 6 months.
干预措施: Dapagliflozin (Drug)
Gemigliptin group
Gemigliptin 50mg for 6 months.
干预措施: Gemigliptin (Drug)
结局指标
主要结局
Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid
时间窗: 6 months
The change of acetoacetate, total ketone, beta-hydroxybutyric acid from baseline to 6 months follow-up
Change (%) in LV mass index
时间窗: 6 months
The change of LV mass index from baseline to 6 months follow-up
次要结局
- Change (%) in LV ejection global longitudinal strain(6 months)
- Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure(6 months)
研究者
Dong-Hyuk Cho
Assistant Professor
Wonju Severance Christian Hospital
