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临床试验/NCT05194592
NCT05194592招募中4 期

Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes

Wonju Severance Christian Hospital1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2022年1月7日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Dapagliflozin 10mg for 6 months.

干预措施: Dapagliflozin (Drug)

Gemigliptin group

Placebo Comparator

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

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong-Hyuk Cho

Assistant Professor

Wonju Severance Christian Hospital

研究点 (1)

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