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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: heart rate variability test

• Study Type: Observational
• Enrollment (Estimated): 155

Contacts and Locations

• Study Contact: Name: Hala A. Abo El-Hassan, MSC; Phone Number: 002/01114851485; Email: hala.aboelhassan@pua.edu.eg
• Study Contact Backup: Name: noha A. Hamdy, Dr.; Phone Number: 002/01005182151; Email: noha.alaaeldine@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University
    • Contact: Hala A. Abo El-Hassan, MSc; Phone Number: 02/01114851485; Email: hala.aboelhassan@pua.edu.eg
    • Contact: Noha A. Hamdy, Dr; Phone Number: 02/01005182151; Email: noha.alaaeldine@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients aged 18-70 Years either diabetic, pre-diabetic or non-diabetic should not have one of the following 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
• Amputated patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: heart 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.; Other Names: blood tests; Cardiac autonomic reflex tests (CARTs)
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 100 mg/dL to 125 mg/dL. Fasting is defined as no caloric intake for at least 8 hours.	Diagnostic test: heart 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.; Other Names: blood tests; Cardiac autonomic reflex tests (CARTs)
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.	Diagnostic test: heart 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.; Other Names: blood tests; Cardiac autonomic reflex tests (CARTs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beat-to-beat Heart rate variability	•It will be measured Different stages of metabolic diseases among non-diabetic, diabetic and prediabetic subjects	one year
body mass index	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.	one year
Valsalva ratio	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	one year
Stand 30:15 ratio	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).	one year
deep breath test interpretation	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.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Framingham risk score (FRS)	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.	one year

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Labiba K. El-Khordagui, Prof. Dr., Alexandria University; Study Director: Ahmed F. El-Yazbi, Prof. Dr., Alamein International University and Alexandria University; Study Director: Mohamed I. Sanhoury, Ass. prof., Alexandria University

Publications and helpful links

General Publications

• American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S20-S42. doi: 10.2337/dc24-S002.
• Risk M, Bril V, Broadbridge C, Cohen A. Heart rate variability measurement in diabetic neuropathy: review of methods. Diabetes Technol Ther. 2001 Spring;3(1):63-76. doi: 10.1089/152091501750220028.
• Bosomworth NJ. Practical use of the Framingham risk score in primary prevention: Canadian perspective. Can Fam Physician. 2011 Apr;57(4):417-23.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 21, 2026

Study Registration Dates

• First Submitted: February 11, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: 0107766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No