Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Flow Mediated Dilation
研究概览
简要总结
The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients.
详细描述
Rosiglitazone and glyburide are two commonly used diabetic medications that have both been shown to be effective in controlling blood glucose levels. Since they work in different ways, they may have different effects on the health of the blood vessels. This study will assess which medication is better at improving the health of the arteries separate from the blood glucose lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25-75 years
- •Type 2 diabetes mellitus for less than or equal to 10 years
- •Pre-screening HbA1c > 6.5 %
- •Screening 110 mg/dl < fasting plasma glucose < 240 mg/dl after 2 weeks of metformin 500 mg twice daily (b.i.d.)
排除标准
- •Thiazolidinedione or sulfonylurea use in previous 30 days (may undergo washout period of 30 days)
- •Known contraindications to use of thiazolidinedione or sulfonylurea
- •Female patients must be postmenopausal, surgically sterile, or using adequate contraception
- •Uncontrolled hyperlipidemia according to American Heart Association (AHA) guidelines
- •Subcutaneous insulin use
- •Elevated liver enzymes (2.5 times the upper limit of the reference range)
- •Serum creatinine >160 mmol/l
- •Anemia (Hb <11 g/dl for men or <10 g/dl for women)
- •Body mass index (BMI) <22 or >42 kg/m2
- •History of ketoacidosis
- •Angina/New York Health Academy class III/IV cardiac insufficiency
- •Electrocardiographic evidence of marked left ventricular hypertrophy
- •Uncontrolled hypertension according to AHA guidelines
- •Hemoglobinopathy
研究组 & 干预措施
Rosiglitazone
干预措施: rosiglitazone (Drug)
Glyburide
干预措施: glyburide (Drug)
结局指标
主要结局
Flow Mediated Dilation
时间窗: change from baseline to 6 months
Measure of endothelial function
次要结局
未报告次要终点
研究者
Aaron S. Kelly, Ph.D.
Assistant Professor
University of Minnesota