Clinical trial NCT05194592: Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes
Official title: Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type2 Diabetes
Remodeling, Ventricular
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 122
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid
timeFrame: 6 months
measure: Change (%) in LV mass index
timeFrame: 6 months
Secondary outcomes:
measure: Change (%) in LV ejection global longitudinal strain
timeFrame: 6 months
measure: Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju College of Medicine
state: Gangwondo
Study officials:
References:
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