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NCT Number: NCT06305195

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria university

Alexandria, Egypt

Location status: Recruiting

Location contact

Hala A. Abo El-Hassan, MSc

CONTACT

[email protected]

02/01114851485

Noha A. Hamdy, Dr

CONTACT

[email protected]

02/01005182151

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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

Treatment and study plan

heart rate variability test

Diagnostic 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.

Other names: Cardiac autonomic reflex tests (CARTs), blood tests

Primary outcomes

  1. Beat-to-beat Heart rate variability

    Time frame: one year

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

  2. body mass index

    Time frame: 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.

  3. Valsalva ratio

    Time frame: 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

  4. Stand 30:15 ratio

    Time frame: 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).

  5. deep breath test interpretation

    Time frame: 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.

Secondary outcomes

  1. Framingham risk score (FRS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hala A. Abo El-Hassan, MSC

CONTACT

[email protected]

002/01114851485

noha A. Hamdy, Dr.

CONTACT

[email protected]

002/01005182151

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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