Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2025-12-31 @ 5:58 AM
Study NCT ID:
NCT06305195
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-10-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-10', 'studyFirstSubmitDate': '2024-02-11', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beat-to-beat Heart rate variability', 'timeFrame': 'one year', 'description': '•It will be measured Different stages of metabolic diseases among non-diabetic, diabetic and prediabetic subjects'}, {'measure': 'body mass index', 'timeFrame': 'one year', 'description': 'Measuring body weight in kilograms (kg) and height in centimeters (cm) to calculate the Body Mass Index (BMI) in kg/m\\^2, a key indicator of healthy weight that can help identify potential health risks.'}, {'measure': 'Valsalva ratio', 'timeFrame': 'one year', 'description': 'The Valsalva ratio is the proportion of the highest and lowest heart rate during and immediately after performing a Valsalva maneuver. A value of 1.21 or more is defined as a normal response'}, {'measure': 'Stand 30:15 ratio', 'timeFrame': 'one year', 'description': 'The Stand 30:15 ratio is the ratio of the highest heart rate during (occurring approximately 15 sec after the initiation of standing) and immediately following standing up from a supine position (occurring approximately 30 sec after the initiation of standing).'}, {'measure': 'deep breath test interpretation', 'timeFrame': 'one year', 'description': 'The heart rate response to deep breathing test was calculated as the difference between maximum heart rate during inhalation and minimum heart rate during exhalation.\n\nA difference of 15 beats/min or more is considered parasympathetic activation.'}], 'secondaryOutcomes': [{'measure': 'Framingham risk score (FRS)', 'timeFrame': 'one year', 'description': 'The Framingham risk score predicts cardiovascular disease risk in asymptomatic patients. The risk is considered low if Framingham Risk Score is less than 10%, moderate if it is 10% to 19%, and high if it is higher than 20%. Heart rate variability (HRV) may be correlated with the Framingham risk score when analyzing the effects of different anti-diabetic drugs. It is expected that if the Heart Rate Variability decreases, the Framingham score will increase, indicating a higher risk of Atherosclerotic Cardiovascular disease risk in the next 10 years. Conversely, if Heart Rate Variability increases, the Framingham score may decrease, indicating a reduced risk of Atherosclerotic cardiovascular disease risk.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '38078589', 'type': 'RESULT', '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.'}, {'pmid': '11469709', 'type': 'RESULT', '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.'}, {'pmid': '21626897', 'type': 'RESULT', 'citation': 'Bosomworth NJ. Practical use of the Framingham risk score in primary prevention: Canadian perspective. Can Fam Physician. 2011 Apr;57(4):417-23.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHeart rate variability will be compared for some antidiabetic drugs used in different stages of metabolic diseases and correlated to different metabolic and inflammatory mediators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged 18-70 Years either diabetic, pre-diabetic or non-diabetic should not have one of the following criteria:\n\n* Pediatric and elderly subjects\n* Pregnant subjects\n* Those with active Myocardial infarction\n* Those with acute decompensated heart failure\n* Patients with pacemaker\n* Patients with persistent Atrial fibrillation, long-standing persistent and permanent Atrial fibrillation\n* Amputated patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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\n2. Pre-diabetic: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria :\n\n * glycated hemoglobin (HBA1C) =5.7-6.4%\n * Fasting blood glucose level = 100 mg/dL to 125 mg/dL. Fasting is defined as no caloric intake for at least 8 hours.\n3. Diabetic patients: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria:\n\n * glycated hemoglobin (HBA1C) ≥6.5%\n * Fasting blood glucose ≥126 mg/dL.\n * A random plasma glucose ≥200 mg/dL. Random is any time of the day without regard to the meals.\n\nExclusion Criteria:\n\n* Pediatric and elderly subjects\n* Pregnant subjects\n* Those with active Myocardial infarction\n* Those with acute decompensated heart failure\n* Patients with pacemaker\n* Patients with persistent Atrial fibrillation, long-standing persistent and permanent Atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT06305195', 'briefTitle': 'Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome: Impact of Some Antidiabetic Drugs', 'orgStudyIdInfo': {'id': '0107766'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-diabetic individuals', 'description': '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', 'interventionNames': ['Diagnostic Test: heart rate variability test']}, {'label': 'Pre-diabetic:', 'description': 'adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria :\n\n* glycated hemoglobin (HBA1C) =5.7-6.4%\n* Fasting blood glucose 100 mg/dL to 125 mg/dL. Fasting is defined as no caloric intake for at least 8 hours.', 'interventionNames': ['Diagnostic Test: heart rate variability test']}, {'label': 'Diabetic patients :', 'description': 'adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria:\n\n* glycated hemoglobin (HBA1C) ≥6.5%\n* Fasting blood glucose ≥126 mg/dL.\n* A random plasma glucose ≥200 mg/dL. Random is any time of the day without regard to the meals.', 'interventionNames': ['Diagnostic Test: heart rate variability test']}], 'interventions': [{'name': 'heart rate variability test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Cardiac autonomic reflex tests (CARTs)', 'blood tests'], 'description': 'First, the patient is required to lie on their back to have a 5-minute continuous ECG recorded, without performing any maneuvers.\n\nFollowing this, deep breath test, Valsalva and stand test are performed.', 'armGroupLabels': ['Diabetic patients :', 'Non-diabetic individuals', 'Pre-diabetic:']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hala A. Abo El-Hassan, MSc', 'role': 'CONTACT', 'email': 'hala.aboelhassan@pua.edu.eg', 'phone': '02/01114851485'}, {'name': 'Noha A. Hamdy, Dr', 'role': 'CONTACT', 'email': 'noha.alaaeldine@alexu.edu.eg', 'phone': '02/01005182151'}], 'facility': 'Alexandria university', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Hala A. Abo El-Hassan, MSC', 'role': 'CONTACT', 'email': 'hala.aboelhassan@pua.edu.eg', 'phone': '002/01114851485'}, {'name': 'noha A. Hamdy, Dr.', 'role': 'CONTACT', 'email': 'noha.alaaeldine@alexu.edu.eg', 'phone': '002/01005182151'}], 'overallOfficials': [{'name': 'Labiba K. El-Khordagui, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Ahmed F. El-Yazbi, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alamein International University and Alexandria University'}, {'name': 'Mohamed I. Sanhoury, Ass. prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teacher assistant', 'investigatorFullName': 'Hala Abo El Hassan', 'investigatorAffiliation': 'Alexandria University'}}}}