Type 2 Diabetes Mellitus
Conditions
Keywords
Cardiac remodeling, SGLT2 inhibitor, T2DM, Dapagliflozin
Brief summary
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.
Detailed description
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.
Interventions
DRUGDiabetes Medicines
Anti-diabetic medications except SGLT2 inhibitors
DRUGDapagliflozin
Dapagliflozin tablet (10 mg)
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female affected by type 2 diabetes mellitus (T2D) for at least 6 months. * Age ≥ 20 and ≤ 80 years. * HbA1c levels 7.1%\ 9.0% . * On stable (at least 3 months) antidiabetic therapy with SGLT2 inhibitors naive. * On stable (at least 3 months) cardio-active therapies (e.g. anti-hypertensive drugs, diuretics or drugs for hyperlipidemia). * Preserved kidney function as defined by estimated glomerular filtration rate(eGFR)\> 60 mL/min/1.73m2. * Preserved left ventricular function defined as EF ≥ 50% by echocardiographic screening.
Exclusion criteria
Subjects should not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac global longitudinal strain (GLS) | Baseline to Week 24 | The primary outcome is to measure the change in cardiac GLS from baseline to 6 months after dapagliflozin treatment compared to standard diabetes care. |
| Left ventricular mass index | Baseline to Week 24 | The primary outcome is to measure the change in LVMi from baseline to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline to Week 24 | Change in HbA1c (%) by echocardiographic measurement over 24 weeks |
| Fasting glucose | Baseline to Week 24 | Change in fasting glucose level over 24 weeks |
| Homeostatic Model Assessment of Insulin Resistance, HOMA-IR | Baseline to Week 24 | Change in HOMA-IR over 24 weeks |
| Plasma biomarker: N-terminal pro-brain natriuretic peptide (NTproBNP) | Baseline to Week 24 | Change of NT-proBNP level (pg/mL) over 24 weeks |
| Anthropometric measures by body mass index (BMI) | Baseline to Week 24 | 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 |
| Plasma biomarker: Growth differentiation factor-15 (GDF-15) | Baseline to Week 24 | Change of GDF-15 level (ng/L) over 24 weeks |
| tumor necrosis factor receptor I (TNF-RI) | Baseline to Week 24 | Change of TNF-RI level (ng/mL) over 24 weeks |
| Plasma biomarker: fatty acid binding protein 4 (FABP-4) | Baseline to Week 24 | Change of FABP-4 level (IU/mL) over 24 weeks |
| transforming growth factor beta 1 (TGF-β1) | Baseline to Week 24 | Change of TGF-β1 level (μg/L) over 24 weeks |
| Blood pressure | Baseline to Week 24 | Change in SBP/DBP level (mmHg) over 24 weeks |
Countries
Taiwan
Outcome results
None listed