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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 :
|
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| Diabetic patients : | adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heart rate variability test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Beat-to-beat Heart rate variability | •It will be measured Different stages of metabolic diseases among non-diabetic, diabetic and prediabetic subjects | one year |
| body mass index | 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. | one year |
| Valsalva ratio | 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 | one year |
| Stand 30:15 ratio | 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). | one year |
| deep breath test interpretation | 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. A difference of 15 beats/min or more is considered parasympathetic activation. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Framingham risk score (FRS) | 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. |
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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 :
Diabetic patients: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria:
Exclusion Criteria:
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patients aged 18-70 Years either diabetic, pre-diabetic or non-diabetic should not have one of the following criteria:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hala A. Abo El-Hassan, MSC | Contact | 002/01114851485 | hala.aboelhassan@pua.edu.eg | |
| noha A. Hamdy, Dr. | Contact | 002/01005182151 | noha.alaaeldine@alexu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Labiba K. El-Khordagui, Prof. Dr. | Alexandria University | Study Director |
| Ahmed F. El-Yazbi, Prof. Dr. | Alamein International University and Alexandria University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria university | Recruiting | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38078589 | Result | 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. | |
| 11469709 | Result | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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blood
|
| one year |
| Mohamed I. Sanhoury, Ass. prof. |
| Alexandria University |
| Study Director |
| 21626897 | Result | Bosomworth NJ. Practical use of the Framingham risk score in primary prevention: Canadian perspective. Can Fam Physician. 2011 Apr;57(4):417-23. |