Examining heart rate variability and cardiovascular risk in metabolic syndrome stages
Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome: Impact of Some Antidiabetic Drugs
Alexandria University · NCT06305195
This study is testing how heart rate changes relate to heart risks in people with different stages of metabolic syndrome, including those who are non-diabetic, pre-diabetic, and diabetic, while also looking at how diabetes medications might affect these heart rate changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 155 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Alexandria University (other) |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT06305195 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between heart rate variability (HRV) and cardiovascular risk across different stages of metabolic syndrome, including non-diabetic, pre-diabetic, and diabetic patients. It aims to compare HRV among these groups and analyze the effects of various antidiabetic medications on HRV, alongside metabolic and inflammatory markers. Participants will undergo HRV testing to gather data that could enhance understanding of cardiovascular risks associated with metabolic disorders.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 who are non-diabetic, pre-diabetic, or diabetic based on specific blood glucose and HbA1c criteria.
Not a fit: Patients who are pediatric, elderly, pregnant, or have certain cardiac conditions such as active myocardial infarction or persistent atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into cardiovascular risks in metabolic syndrome, potentially leading to improved management strategies for patients.
How similar studies have performed: While there have been studies examining HRV in relation to metabolic conditions, this specific correlation with cardiovascular risk at various metabolic syndrome stages is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Alexandria
- Alexandria university — Alexandria, Egypt (RECRUITING)
Study contacts
- Study coordinator: Hala A. Abo El-Hassan, MSC
- Email: hala.aboelhassan@pua.edu.eg
- Phone: 002/01114851485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus