A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life (HRQoL)
研究概览
简要总结
The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will assess the use of the medication metformin to improve quality of life, exercise capacity, and improved outcomes in heart failure patients with pre-DM or early DM (type II).
If the patient participates in this study, the patient will receive the drug metformin for approximately 3 months. During the study the patient will undergo comprehensive testing which includes blood draws and echocardiograms. The patient will also fill out a questionnaire. The patient must be 18 years old to participate.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic HF of any etiology
- •age ≥ 18 years
- •fasting blood sugar equal or greater than 100 mg/dL, or pre-DM (HbA1c 5.7 - 6.4%) or early DM (HbA1c ≥ 6.5%)
排除标准
- •current metformin therapy or other anti-diabetic therapy
- •previous intolerance to metformin therapy
- •renal dysfunction (Cr >1.5 in men or > 1.4 in women or creatinine clearance < 60 ml/minute)
- •history of lactic acidosis
- •current or planned pregnancy or breast-feeding
研究组 & 干预措施
Metformin
Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month.
干预措施: Metformin (Drug)
结局指标
主要结局
Health-Related Quality of Life (HRQoL)
时间窗: 3 months
HRQoL as assessed by the Minnesota Living With Heart Failure Questionnaire (MLHFQ) The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score range 0-105. Lower scores indicate better health-related quality of life (HRQoL).
次要结局
- Creatinine Level as a Measure of Renal Function(3 months)
- Glycated Hemoglobin (HbA1c)(3 months)
- Left Ventricular Ejection Fraction (LVEF)(3 months)
研究者
Tamara Horwich
Tamara Horwich, MD, MS
University of California, Los Angeles