Effect of Sitagliptin on Insulin Resistance and Myocardial Metabolism in Heart Failure
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Determine the Effects of Sitagliptin on Myocardial Glucose Uptake in Patients With Nonischemic Cardiomyopathy
研究概览
简要总结
This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.
This study will also investigate the effect of sitagliptin on the body's use of sugar, and of the effect of sitagliptin on blood flow to the heart.
详细描述
Screening:
Patients will be screened based on existing clinic information regarding NYHA class (New York Heart Association functional class) and heart failure characteristics. Patients will be approached in clinic after completing clinical care for that visit regarding participation in this trial.
If the patient agrees to participate, informed consent will be obtained at this time.
At enrollment:
Patients will be queried as to whether they have undergone previous nuclear medicine scans in the previous year in order to ensure that they do not exceed current standards for total annual radiation exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-III congestive heart failure
- •Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)
- •Age > 18 yrs
排除标准
- •Cardiomyopathy primarily due to one of the following:
- •Ischemic heart disease
- •Primary valvular lesion
- •Hypertrophic cardiomyopathy
- •Cardiac resynchronization within the last 3 months
- •Calculated creatinine clearance <30 ml/min or end-stage renal disease on dialysis. Creatinine clearance will be determined by the Cockcroft-Gault formula.
- •Diagnosis of diabetes mellitus by:
- •Diabetes previously diagnosed per patient history
- •2 or more fasting glucose values > 125 mg/dl
- •History of heart transplantation
- •Pregnancy or active breast feeding
- •Hospitalization for decompensated heart failure within 30 days prior to enrollment.
研究组 & 干预措施
All subjects recieve Sitagliptin
All subjects are aware of what they are taking. Nobody is blinded in this study. study
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Determine the Effects of Sitagliptin on Myocardial Glucose Uptake in Patients With Nonischemic Cardiomyopathy
时间窗: 2008-2012
This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.
Determine the Effects of Sitagliptin on Myocardial Glucose Uptake Measured by Myocardial PET Scan
时间窗: 30 days
This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. Baseline glucose uptake scans will be compared with the scans on sitagliptin thirty days after baseline
次要结局
- Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy(4 years)