Diabetes Mellitus
Conditions
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.
Interventions
DIAGNOSTIC_TESTheart 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.
Sponsors
Alexandria University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beat-to-beat Heart rate variability | one year | •It will be measured Different stages of metabolic diseases among non-diabetic, diabetic and prediabetic subjects |
| body mass index | one year | 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. |
| Valsalva ratio | one year | 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 |
| Stand 30:15 ratio | one year | 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). |
| deep breath test interpretation | one year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Framingham risk score (FRS) | one year | 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. |
Countries
Egypt
Contacts
Primary ContactHala A. Abo El-Hassan, MSC
Backup Contactnoha A. Hamdy, Dr.
Outcome results
None listed