Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Epicardial Fat Thickness
研究概览
简要总结
The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes, as defined by ADA criteria
- •HbA1c < 8% measured at least 1 week prior to the study
- •BMI ≥27 kg/m2
- •Pre-treatment with Metformin as monotherapy
- •Age > 18 and < 65 years old
- •Normal and stable hemodynamic status
排除标准
- •Known contra-indications to Farxiga, in accordance with risks and safety information included in the latest updated Prescribing Information
- •Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
- •Insulin dependent or treated type 2 diabetes
- •Current use of other SGLT2 inhibitors, Glucagon Like Peptide -1 (GLP- 1) analogs or Dipeptidyl Peptidase 4 (DPP4) inhibitors
- •Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2
- •Signs or symptoms of hypovolemia
- •Patients with poor glycemic control (HbA1c ≥ 8%) will be excluded to maximize long-term patient retention without need
- •History of diabetes ketoacidosis
- •Patients with active bladder cancer or with a prior history of bladder cancer
- •Acute or chronic infective, including genital mycotic infections
- •Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
- •Clinical or laboratory evidences of chronic active liver diseases
- •Acute or chronic infective diseases
- •Cancer or chemotherapy
- •Current use of systemic corticosteroids or in the 3 months prior this study
- •Known or suspected allergy to Dapagliflozin, excipients, or related products
- •Pregnant, breast-feeding or the intention of becoming pregnant
- •Females of childbearing potential who are not using adequate contraceptive methods
研究组 & 干预措施
Dapagliflozin and Metformin Group
Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.
干预措施: Dapagliflozin (Drug)
Dapagliflozin and Metformin Group
Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.
干预措施: Metformin (Drug)
Metformin and Placebo Group
Participants in this group will receive Metformin and Placebo for 6 months.
干预措施: Metformin (Drug)
Metformin and Placebo Group
Participants in this group will receive Metformin and Placebo for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Epicardial Fat Thickness
时间窗: At Baseline, 12 weeks, 24 weeks
Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks
次要结局
- Left Ventricular Mass (LVM)(At Baseline, Week 12 and Week 24)
研究者
Gianluca Iacobellis
Professor of Clinical Medicine
University of Miami