The primary purpose of this study is to evaluate the efficacy of the SGLT2 inhibitor dapagliflozin, as compared with standard care of diabetes, on left ventricular (LV) structural and functional change in asymptomatic type 2 diabetes mellitus (DM) patient.
The ELUCIDATE trial is a prospective, open label, randomized, active-controlled 'proof of concept'single centre study conducted in Mackay Memorial Hospital, Taipei, Taiwan. It is designed to clarify the LV remodeling by using Speckle-Tracking echocardiography to measure cardiac global longitudinal strain (GLS). A cohort of 90 type 2 DM patients with normal LV ejection fraction will be randomized to either dapagliflozin 10 mg/die or to standard of care group as an active comparator. The study consists of 5 visits (see Table 1) and will last half an year, which has been ongoing since February 2019. The primary outcomes are to detect the changes in LV mass index and cardiac GLS from baseline to 6 months after treatment initiation. The secondary outcomes include changes from baseline to 6 months in anthropometric measures, atrial-ventricular mechanics measurements, HbA1C,Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), epicardial fat and plasma biomarkers regarding cardiomyocyte remodeling and inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Anti-diabetic medications except SGLT2 inhibitors
Dapagliflozin tablet (10 mg)
Mackay Memorial Hospital
Taipei, Taiwan
Cardiac global longitudinal strain (GLS)
The primary outcome is to measure the change in cardiac GLS from baseline to 6 months after dapagliflozin treatment compared to standard diabetes care.
Time frame: Baseline to Week 24
Left ventricular mass index
The primary outcome is to measure the change in LVMi from baseline to 6 months
Time frame: Baseline to Week 24
Anthropometric measures by body mass index (BMI)
Body weight in kilograms, body height in meters Body weight and height will be combined to report BMI in kg/m\^2 Compare the change in anthropometric measures from baseline to 6 months
Time frame: Baseline to Week 24
Blood pressure
Change in SBP/DBP level (mmHg) over 24 weeks
Time frame: Baseline to Week 24
HbA1c
Change in HbA1c (%) by echocardiographic measurement over 24 weeks
Time frame: Baseline to Week 24
Fasting glucose
Change in fasting glucose level over 24 weeks
Time frame: Baseline to Week 24
Homeostatic Model Assessment of Insulin Resistance, HOMA-IR
Change in HOMA-IR over 24 weeks
Time frame: Baseline to Week 24
Plasma biomarker: N-terminal pro-brain natriuretic peptide (NTproBNP)
Change of NT-proBNP level (pg/mL) over 24 weeks
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Time frame: Baseline to Week 24
transforming growth factor beta 1 (TGF-β1)
Change of TGF-β1 level (μg/L) over 24 weeks
Time frame: Baseline to Week 24
Plasma biomarker: Growth differentiation factor-15 (GDF-15)
Change of GDF-15 level (ng/L) over 24 weeks
Time frame: Baseline to Week 24
tumor necrosis factor receptor I (TNF-RI)
Change of TNF-RI level (ng/mL) over 24 weeks
Time frame: Baseline to Week 24
Plasma biomarker: fatty acid binding protein 4 (FABP-4)
Change of FABP-4 level (IU/mL) over 24 weeks
Time frame: Baseline to Week 24