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

Alexandria University

Status: Enrolling

Conditions: Diabetes Mellitus

Treatments: Diagnostic Test: heart rate variability test

Study type: Observational

Funder types: Other

Identifiers

NCT06305195

0107766

Details and patient eligibility

About

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.

Enrollment: 155 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

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

Trial design

155 participants in 3 patient groups

Non-diabetic individuals

Description:

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

Treatment:

Diagnostic Test: heart rate variability test

Pre-diabetic:

Description:

adults (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.

Treatment:

Diagnostic Test: heart rate variability test

Diabetic patients :

Description:

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.

Treatment:

Diagnostic Test: heart rate variability test