Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: heart rate variability test.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome: Impact of Some Antidiabetic Drugs
Overview
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.
Interventions
- 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.
Primary outcome measures
- Beat-to-beat Heart rate variability [Time frame: one year]
- body mass index [Time frame: one year]
- Valsalva ratio [Time frame: one year]
- Stand 30:15 ratio [Time frame: one year]
- deep breath test interpretation [Time frame: one year]
Secondary outcome measures (1)
- Framingham risk score (FRS) [Time frame: one year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Alexandria university — Alexandria
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. PMID 38078589
- 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
- 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
Identifiers
NCT: NCT06305195 · 0107766