The Effect of Postprandial Hyperglycemia on the Arterial Stiffness in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast
研究概览
简要总结
This Study is looking at whether high blood glucose levels after a meal affect arterial stiffness more or less than low blood glucose levels, and whether certain cardiovascular markers influence the outcome of this.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Are diagnosed with T2DM (according to the American Diabetes Association classification [American Diabetes Association 2006]) and on insulin therapy for at least 6 months.
- •Have not smoked in the last 12 hours prior to the study visit.
- •Have albuminuria but normal kidney function or normal UAER [UAER < 20 micrograms per minute (mcg/min) or < 30 milligrams/24 hours (mg/24h), respectively]. Participants with or without albuminuria but normal kidney function will be matched for age and body mass index (BMI).
- •Participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
- •Each participant must understand the nature of the study and must sign an informed consent document (ICD).
- •Healthy participants are eligible to be included in the study only if they meet all of the following criteria:
- •Healthy participants 45 to 70 years of age, matched for age and BMI, who have not smoked in the last 12 hours prior to the study.
- •Normal glucose tolerance and normal UAER (UAER between < 20 μg/min in the overnight urine collection or < 30 mg/24h in the 24-h urine collection).
- •Healthy participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
- •Each healthy participant must understand the nature of the study and must sign an ICD.
排除标准
- •Participants/healthy participants will be excluded from the study if they meet any of the following criteria:
- •Have had a cardiovascular event [stroke, myocardial infarction (MI), coronary artery procedure (by-pass surgery or angioplasty), limb amputation due to ischemia, peripheral vascular disease] or coronary heart disease confirmed by exercise test or scintigraphy.
- •Have arrhythmias.
- •Have an acute infection.
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant.
研究组 & 干预措施
T2DM, albuminuria but normal kidney function
干预措施: Lispro (Drug)
T2DM, normal urinary albumin excretion rate (UAER)
干预措施: Lispro (Drug)
结局指标
主要结局
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast
时间窗: 180 mins (post-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast
时间窗: 30 mins (pre-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast
时间窗: 60 mins (post-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast
时间窗: 240 mins (post-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast
时间窗: 120 mins (post-breakfast)
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
次要结局
- Change in Pulse Wave Amplitude (PWA)(30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast))
- Change in Peripheral Artery Tonometry (PAT)(30 mins (pre-breakfast), 120 and 240 mins (post-breakfast))
- Change in QT Interval on Electrocardiogram (ECG)(30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast))
- Change in Blood Glucose (BG)(30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast))
- Change in Postprandial Pulse Wave Velocity (PWV)(30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast))