Clinical trial NCT06305195: Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome
Official title: Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome: Impact of Some Antidiabetic Drugs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Beat-to-beat Heart rate variability
timeFrame: one year
measure: body mass index
timeFrame: one year
measure: Valsalva ratio
timeFrame: one year
measure: Stand 30:15 ratio
timeFrame: one year
measure: deep breath test interpretation
timeFrame: one year
Secondary outcomes:
measure: Framingham risk score (FRS)
timeFrame: one year
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
affiliation: Alexandria University
name: Labiba K. El-Khordagui, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Alamein International University and Alexandria University
name: Ahmed F. El-Yazbi, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Mohamed I. Sanhoury, Ass. prof.
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: Bosomworth NJ. Practical use of the Framingham risk score in primary prevention: Canadian perspective. Can Fam Physician. 2011 Apr;57(4):417-23.