The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Reactive Hyperemic Index Over the 3-month Treatment Period
研究概览
简要总结
The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.
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
- 否
入选标准
- •Greater than or equal to 18 years old
- •Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose >140 mg/dL OR impaired fasting glucose: fasting glucose > or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c > or = 5.7%
- •Abdominal obesity: waist circumference >102 cm (men) and >88 cm (women)
- •Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study
排除标准
- •Type 2 diabetes
- •Current use of glycemic control medications within one month of randomization
- •Fasting glucose >126 mg/dL
- •Current use of weight loss medication
- •Previous weight loss surgery
- •History of severe gastrointestinal disease
- •Standard clinical contraindications to exenatide or metformin therapy
- •Unstable angina
- •Heart failure
- •Stroke or coronary artery bypass graft within 3 months of screening
- •Women who are currently pregnant or planning to become pregnant
- •Breastfeeding women
- •Clinically significant liver disease
- •Creatinine > 1.5 mg/dL
- •Hepatic function greater than 3 times upper limit of normal
- •Patients who are mentally incompetent and cannot sign a Patient Informed Consent
研究组 & 干预措施
Exenatide
Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
干预措施: Exenatide (Drug)
Metformin
Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
干预措施: Metformin (Drug)
结局指标
主要结局
Change in Reactive Hyperemic Index Over the 3-month Treatment Period
时间窗: Change from baseline to 3 months
Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.
次要结局
未报告次要终点
研究者
Aaron S. Kelly, Ph.D.
Assistant Professor
University of Minnesota