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

NCT06305195 | Recruiting

• 1 other identifier: 0107766
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Framingham risk score (FRS)

  one year

Study Arms (3)

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

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

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

Interventions

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.

Also known as: Cardiac autonomic reflex tests (CARTs), blood tests

Diabetic patients :; Non-diabetic individuals; Pre-diabetic:

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria university

Alexandria, Egypt

RECRUITING

Related 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.

  PMID: 38078589 RESULT

• 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.

  PMID: 11469709 RESULT

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

  PMID: 21626897 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

Hala A. Abo El-Hassan, MSC

CONTACT

002/01114851485; hala.aboelhassan@pua.edu.eg

noha A. Hamdy, Dr.

CONTACT

002/01005182151; noha.alaaeldine@alexu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher assistant

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: March 12, 2024
• Study Start: August 23, 2023
• Primary Completion: September 1, 2024
• Study Completion (Estimated): October 21, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)