RecruitingNCT06305195

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

Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome: Impact of Some Antidiabetic Drugs


Sponsor

Alexandria University

Enrollment

155 participants

Start Date

Aug 23, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

  • 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.

Exclusion Criteria6

  • 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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Interventions

DIAGNOSTIC_TESTheart rate variability test

First, the patient is required to lie on their back to have a 5-minute continuous ECG recorded, without performing any maneuvers. Following this, deep breath test, Valsalva and stand test are performed.


Locations(1)

Alexandria university

Alexandria, Egypt

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NCT06305195


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