Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome
NCT ID: NCT06305195
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
155 participants
OBSERVATIONAL
2023-08-23
2026-10-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Continuous Heart Rate Monitoring in Healthy Participants
NCT04682184
Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers
NCT03485482
Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes
NCT00123604
Effects of Cardiac Sympathetic Blockade in Patients With Chronic Heart Failure
NCT02282618
Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients
NCT00744237
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alexandria University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hala Abo El Hassan
Teacher assistant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Labiba K. El-Khordagui, Prof. Dr.
Role: STUDY_DIRECTOR
Alexandria University
Ahmed F. El-Yazbi, Prof. Dr.
Role: STUDY_DIRECTOR
Alamein International University and Alexandria University
Mohamed I. Sanhoury, Ass. prof.
Role: STUDY_DIRECTOR
Alexandria University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alexandria university
Alexandria, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Bosomworth NJ. Practical use of the Framingham risk score in primary prevention: Canadian perspective. Can Fam Physician. 2011 Apr;57(4):417-23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0107766
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.