The Echocardiographic Left Ventricular Functional Changes of Uncontrolled Diabetes by the Intervention of Dapagliflozin Treatment Trial (ELUCIDATE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Cardiac global longitudinal strain (GLS)
研究概览
简要总结
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.
详细描述
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.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/1.73m
- •Preserved left ventricular function defined as EF ≥ 50% by echocardiographic screening.
排除标准
- •Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- •Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- •Previous enrolment or randomisation in the present study.
- •Participation in another clinical study with an investigational product during the last 3 months.
- •The exclusion criteria that follow are for example only; include, exclude, modify or add other criteria as appropriate.
- •Refuse or inability to give informed consent.
- •Patients unlikely to comply with the protocol or unable to understand the nature and possible consequences of the study.
- •Employees of the investigator or study centre (i.e. principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
- •Pregnancy or active breast feeding.
- •History of hospitalization for heart failure.
- •History of stage C or D heart failure.
- •History of myocardial infarction.
- •History of cardiac dysrhythmia.
- •Patients with a known hypersensitivity to Dapagliflozin or any of the excipients of the product.
研究组 & 干预措施
Dapagliflozin add-on group
T2D subjects aged 20-80 years, presenting with HbA1C 7.1-9.0%, preserved kidney function (defined as estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2), preserved LV function (defined as EF ≥ 50% by echocardiographic screening in the initial 2-week run-in period), and those treated with oral anti-diabetic drugs (except SGLT2i) and/or insulin therapy at least 3 months prior to the study were randomised to Dapagliflozin (10 mg/qd) add-on group.
干预措施: Diabetes Medicines (Drug)
Dapagliflozin add-on group
T2D subjects aged 20-80 years, presenting with HbA1C 7.1-9.0%, preserved kidney function (defined as estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2), preserved LV function (defined as EF ≥ 50% by echocardiographic screening in the initial 2-week run-in period), and those treated with oral anti-diabetic drugs (except SGLT2i) and/or insulin therapy at least 3 months prior to the study were randomised to Dapagliflozin (10 mg/qd) add-on group.
干预措施: Dapagliflozin (Drug)
Standard of care (SOC) group
T2D subjects aged 20-80 years, presenting with HbA1C 7.1-9.0%, preserved kidney function (defined as estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2), preserved LV function (defined as EF ≥ 50% by echocardiographic screening in the initial 2-week run-in period), and those treated with oral anti-diabetic drugs (except SGLT2i) and/or insulin therapy at least 3 months prior to the study were randomised to SOC treatment group.
干预措施: Diabetes Medicines (Drug)
结局指标
主要结局
Cardiac global longitudinal strain (GLS)
时间窗: 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
时间窗: Baseline to Week 24
The primary outcome is to measure the change in LVMi from baseline to 6 months
次要结局
- Homeostatic Model Assessment of Insulin Resistance, HOMA-IR(Baseline to Week 24)
- Plasma biomarker: N-terminal pro-brain natriuretic peptide (NTproBNP)(Baseline to Week 24)
- Fasting glucose(Baseline to Week 24)
- transforming growth factor beta 1 (TGF-β1)(Baseline to Week 24)
- Plasma biomarker: Growth differentiation factor-15 (GDF-15)(Baseline to Week 24)
- tumor necrosis factor receptor I (TNF-RI)(Baseline to Week 24)
- Plasma biomarker: fatty acid binding protein 4 (FABP-4)(Baseline to Week 24)
- Blood pressure(Baseline to Week 24)
- Anthropometric measures by body mass index (BMI)(Baseline to Week 24)
- HbA1c(Baseline to Week 24)