NCT00766857已完成4 期
The Effect of Exenatide Compared to Insulin Glargine on Cardiac Function and Metabolism in Type 2 Diabetic Patients With Congestive Heart Failure: a Randomized Comparator-controlled Trial
Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).
研究概览
简要总结
The purpose of this study is to determine if exenatide will improve global cardiac function in patients with type 2 diabetes mellitus and congestive heart failure, by favorable effects on cardiac metabolism leading to improvement of cardiac efficiency.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes mellitus
- •Male and postmenopausal female
- •Age 18 years an above
- •Metformin therapy (stable, maximum tolerable dose for 2 months)
- •HbA1c 6.5-10%
- •Confirmed congestive heart failure (NHYA functional class II-IV)
- •Ejection fraction < 50%
- •Patients should receive a stable standard therapy for their cardiac condition for 3 months prior entering the study
排除标准
- •Type 1 diabetes mellitus
- •Serious renal or liver impairment
- •(Receiving treatment for) malignant disease
- •Cardiovascular event < 3 months prior to inclusion
- •Acute congestive heart failure
- •Any reason for not being able to sustain the imaging studies
- •Pacemaker/ICD
- •Contraindications for the use of exenatide/ insulin
- •Use of insulin, thiazolidinediones, incretin-based therapies within 4 months of screening
- •Chronic use of glucocorticoids, NSAIDs or centrally acting drugs (> 2 weeks) within 2 weeks immediately prior to screening
研究组 & 干预措施
1. Exenatide
Experimental
干预措施: exenatide (Drug)
2. Insulin glargine
Active Comparator
干预措施: Insulin glargine (Drug)
结局指标
主要结局
Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).
时间窗: week -2 and week 11
次要结局
- Cardiac function, dimensions and scarring will be measured bij CMR(week -2 and week 26)
- Exercise capacity and performance will be assessed by a 6-minute walking test(week -1 and week 27)
- Cardiac oxygen consumption, cardiac efficiency and stress perfusion will be assessed by Positron Emission Tomography (PET) using 11C-acetate and H2-15O(week -2 and week 26)
- Myocardial diastolic function parameters will be obtained bij trans thoracal echocardiography. Comparisons will be made of strain and torsion measures obtained bij CMR and echocardiography.(week -2 and week 26)
研究者
M.H.H. Kramer
MD, PhD
Amsterdam UMC, location VUmc
研究点 (1)
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