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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305195
• Other study ID #: 0107766
• Status: Recruiting
• Start date: August 23, 2023
• Est. completion date: October 21, 2026

Study information

• Verified date: March 2024
• Source: Alexandria University
• Contact: Hala A. Abo El-Hassan, MSC
• Phone: 002/01114851485
• Email: hala.aboelhassan[@]pua.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: October 21, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 de?ned 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Metabolic Syndrome

Intervention

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.

Locations

Country	Name	City	State
Egypt	Alexandria university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

Bosomworth NJ. Practical use of the Framingham risk score in primary prevention: Canadian perspective. Can Fam Physician. 2011 Apr;57(4):417-23. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beat-to-beat Heart rate variability	•It will be measured Different stages of metabolic diseases among non-diabetic, diabetic and prediabetic subjects	one year
Primary	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
Primary	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
Primary	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
Primary	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	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