NCT06305195 Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome
| NCT ID | NCT06305195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexandria University |
| Condition | Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 155 participants |
| Start Date | 2023-08-23 |
| Primary Completion | 2024-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 155 participants in total. It began in 2023-08-23 with a primary completion date of 2024-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Labiba K. El-Khordagui, Prof. Dr.
STUDY DIRECTOR
Alexandria University
Frequently Asked Questions
Who can join the NCT06305195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06305195 currently recruiting?
Yes, NCT06305195 is actively recruiting participants. Contact the research team at hala.aboelhassan@pua.edu.eg for enrollment information.
Where is the NCT06305195 trial being conducted?
This trial is being conducted at Alexandria, Egypt.
Who is sponsoring the NCT06305195 clinical trial?
NCT06305195 is sponsored by Alexandria University. The principal investigator is Labiba K. El-Khordagui, Prof. Dr. at Alexandria University. The trial plans to enroll 155 participants.
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