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

Recruiting now

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT06305195

Run by

Alexandria University

People needed

155

Starts

2023-08-23

Expected to finish

2026-10-21

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Alexandria university — Alexandria, Egypt (enrolling)

Full record on ClinicalTrials.gov

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