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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06305195
Other study ID # 0107766
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 23, 2023
Est. completion date October 21, 2026

Study information

Verified date March 2024
Source Alexandria University
Contact Hala A. Abo El-Hassan, MSC
Phone 002/01114851485
Email hala.aboelhassan@pua.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 155
Est. completion date October 21, 2026
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 de?ned 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
Egypt Alexandria university Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

Bosomworth NJ. Practical use of the Framingham risk score in primary prevention: Canadian perspective. Can Fam Physician. 2011 Apr;57(4):417-23. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Beat-to-beat Heart rate variability •It will be measured Different stages of metabolic diseases among non-diabetic, diabetic and prediabetic subjects one year
Primary 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
Primary 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
Primary 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
Primary 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
Secondary 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. one year
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