Glycemic Variability Predicts Endothelial Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Serum levels of endothelial dysfunction biomarkers and glycemic variability
研究概览
简要总结
It is well known that lowering average blood glucose decreases the risk of diabetic complications involving the small vessels, such as those found in the eyes, nerves and kidney. It is less clear however, if controlling fluctuations in blood glucose will further help to prevent such complications.
The purpose of this study is to examine the relationship between extreme fluctuations in glucose and damage to the blood vessel lining.
详细描述
Studies have shown that glycemic variability is associated with oxidative stress which in turn has been correlated with endothelial damage. Further, endothelial damage has been identified as a critical event lending way to the vascular complications seen in many disease states.
The specific aim of this study is to investigate the relationship between short-term glycemic variability and biomarkers of endothelial dysfunction while analyzing the influence of different variables and adjusting for covariates.
Data obtained from a continuous glucose monitoring system(CGMS), a device that continuously records interstitial glucose for a 72 hour period, is used to calculate glycemic variability. Serology for the determination of endothelial dysfunction biomarkers is obtained on day three.
Pearson and Spearman Rank Order correlations are utilized to determine whether there are any significant correlations between measures of glycemic variability and biomarker levels of endothelial dysfunction. Multiple regression analysis would also determine if glycemic variability predicts elevated biomarker levels even after controlling for other variables.
Provided the high prevalence of diabetic complications and their staggering socioeconomic costs, it is important to elucidate the relationship between glycemic variability and endothelial dysfunction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects with Type 2 Diabetes Mellitus and glycosylated hemoglobin <8.0%
排除标准
- •Age <18 or >65
- •Baseline glycosylated hemoglobin <6.0% or >8.0%
- •Winthrop University Hospital Employee or Staff member
- •Vulnerable subject
- •Uncontrolled hypertension(defined as systolic blood pressure >130 or diastolic blood pressure >80mmHg)
- •Uncontrolled dyslipidemia (defined as LDL >130mg/dL; HDL <30mg/dL or triglycerides >199mg/dL)
- •Current smoker or significant smoke exposure(defined as greater than 2 hours of exposure to second-hand smoke within the preceding 48hrs)
- •Sympathomimetic use within the past week
- •History of cardiovascular disease
- •History of paroxysmal nocturnal hemoglobinuria
- •History of thrombotic thrombocytopenic purpura
- •History of stage II-V Chronic Kidney Disease
结局指标
主要结局
Serum levels of endothelial dysfunction biomarkers and glycemic variability
时间窗: Day 3 of study enrollment
The following biomarkers are studied: soluble e-selectin, vascular cell adhesion molecule-1, intercellular adhesion molecule-1 and asymmetric dimethylarginine. These analytes are highly correlated to endothelial dysfunction.
次要结局
- Metabolic parameters and glycemic variability(Day 3 of study enrollment)