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Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome

Recruiting
Conditions
Diabetes Mellitus
Interventions
Diagnostic Test: heart rate variability test
Registration Number
NCT06305195
Lead Sponsor
Alexandria University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
155
Inclusion Criteria
  1. 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

  2. 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.
  3. 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.
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Exclusion Criteria
  • 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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Non-diabetic individualsheart rate variability testadults (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:heart rate variability testadults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria : * glycated hemoglobin (HBA1C) =5.7-6.4% * Fasting blood glucose 100 mg/dL to 125 mg/dL. Fasting is defined as no caloric intake for at least 8 hours.
Diabetic patients :heart rate variability testadults (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.
Primary Outcome Measures
NameTimeMethod
body mass indexone 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 ratioone 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 variabilityone year

•It will be measured Different stages of metabolic diseases among non-diabetic, diabetic and prediabetic subjects

Stand 30:15 ratioone 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 interpretationone 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.

Secondary Outcome Measures
NameTimeMethod
Framingham risk score (FRS)one year

The Framingham risk score predicts cardiovascular disease risk in asymptomatic patients. The risk is considered low if Framingham Risk Score is less than 10%, moderate if it is 10% to 19%, and high if it is higher than 20%. Heart rate variability (HRV) may be correlated with the Framingham risk score when analyzing the effects of different anti-diabetic drugs. It is expected that if the Heart Rate Variability decreases, the Framingham score will increase, indicating a higher risk of Atherosclerotic Cardiovascular disease risk in the next 10 years. Conversely, if Heart Rate Variability increases, the Framingham score may decrease, indicating a reduced risk of Atherosclerotic cardiovascular disease risk.

Trial Locations

Locations (1)

Alexandria university

🇪🇬

Alexandria, Egypt

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