Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome: Impact of Some Antidiabetic Drugs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- body mass index
研究概览
简要总结
The study aims to assess the beat-to-beat Heart rate variability (HRV) in different stages of metabolic diseases, including pre-diabetic and diabetic patients, compared to non-diabetic individuals.
Heart rate variability will be compared for some antidiabetic drugs used in different stages of metabolic diseases and correlated to different metabolic and inflammatory mediators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-diabetic individuals: adults (18-70 Years) with glycated hemoglobin (HBA1C)<5.7 and/or Fasting blood glucose <100 mg/L and with no classic symptoms of hyperglycemia
- •Pre-diabetic: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria :
- •glycated hemoglobin (HBA1C) =5.7-6.4%
- •Fasting blood glucose level = 100 mg/dL to 125 mg/dL. Fasting is defined as no caloric intake for at least 8 hours.
- •Diabetic patients: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria:
- •glycated hemoglobin (HBA1C) ≥6.5%
- •Fasting blood glucose ≥126 mg/dL.
- •A random plasma glucose ≥200 mg/dL. Random is any time of the day without regard to the meals.
排除标准
- •Pediatric and elderly subjects
- •Pregnant subjects
- •Those with active Myocardial infarction
- •Those with acute decompensated heart failure
- •Patients with pacemaker
- •Patients with persistent Atrial fibrillation, long-standing persistent and permanent Atrial fibrillation
结局指标
主要结局
body mass index
时间窗: one year
Measuring body weight in kilograms (kg) and height in centimeters (cm) to calculate the Body Mass Index (BMI) in kg/m\^2, a key indicator of healthy weight that can help identify potential health risks.
Valsalva ratio
时间窗: one year
The Valsalva ratio is the proportion of the highest and lowest heart rate during and immediately after performing a Valsalva maneuver. A value of 1.21 or more is defined as a normal response
Beat-to-beat Heart rate variability
时间窗: one year
•It will be measured Different stages of metabolic diseases among non-diabetic, diabetic and prediabetic subjects
Stand 30:15 ratio
时间窗: one year
The Stand 30:15 ratio is the ratio of the highest heart rate during (occurring approximately 15 sec after the initiation of standing) and immediately following standing up from a supine position (occurring approximately 30 sec after the initiation of standing).
deep breath test interpretation
时间窗: one year
The heart rate response to deep breathing test was calculated as the difference between maximum heart rate during inhalation and minimum heart rate during exhalation. A difference of 15 beats/min or more is considered parasympathetic activation.
次要结局
- Framingham risk score (FRS)(one year)
研究者
Hala Abo El Hassan
Teacher assistant
Alexandria University