Diabetes MellitusNCT06305195
Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome
An observational study of Diabetes Mellitus, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- heart rate variability test
- How many people
- 155 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Aug 2023to 21 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients aged 18-70 Years either diabetic, pre-diabetic or non-diabetic should not have one of the following 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 * Amputated patients
Who may be able to join
- 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 :
- 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.
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university
Alexandria
Hala A. Abo El-Hassan, MSc, 02/01114851485, hala.aboelhassan@pua.edu.eg
Noha A. Hamdy, Dr, 02/01005182151, noha.alaaeldine@alexu.edu.eg
About this study
Official title: Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome: Impact of Some Antidiabetic Drugs
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.
- Conditions
- Diabetes Mellitus
- Being tested
- heart rate variability test
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate variability testDiagnostic test
Also called Cardiac autonomic reflex tests (CARTs), blood tests
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: heart rate variability test | |
| 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. Receives: Diagnostic Test: heart rate variability test | |
| 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. Receives: Diagnostic Test: heart rate variability test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beat-to-beat Heart rate variability
•It will be measured Different stages of metabolic diseases among non-diabetic, diabetic and prediabetic subjects
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start23 Aug 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion21 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Abo El Hassan, Alexandria University
- Investigators
- Labiba K. El-Khordagui, Prof. Dr., Study director, Alexandria UniversityAhmed F. El-Yazbi, Prof. Dr., Study director, Alamein International University and Alexandria UniversityMohamed I. Sanhoury, Ass. prof., Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305195
- Sponsor's protocol ID
- 0107766
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38078589Risk 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.
PubMed 11469709Bosomworth NJ. Practical use of the Framingham risk score in primary prevention: Canadian perspective. Can Fam Physician. 2011 Apr;57(4):417-23.
PubMed 21626897
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome: Impact of Some Antidiabetic Drugs
- ClinicalTrials.gov ID
- NCT06305195
- Acronym / sponsor ID
- 0107766
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 21 Oct 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic individuals | – | Diagnostic Test: heart rate variability testadults (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: | – | Diagnostic Test: heart rate variability testadults (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. |
| Diabetic patients : | – | Diagnostic Test: heart rate variability testadults (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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged 18-70 Years either diabetic, pre-diabetic or non-diabetic should not have one of the following 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 * Amputated patients
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (6 listed)
- Pediatric and elderly subjects
- Pregnant subjects
- Those with active Myocardial infarction
- Those with acute decompensated heart failure
- Patients with pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heart rate variability testAlso: Cardiac autonomic reflex tests (CARTs), blood testsFirst, 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. | Diagnostic test | Diabetic patients :, Non-diabetic individuals, Pre-diabetic: |
Primary outcome
Beat-to-beat Heart rate variability
Time frame: one year
•It will be measured Different stages of metabolic diseases among non-diabetic, diabetic and prediabetic subjects
body mass index
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Framingham risk score (FRS)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Results publication: PubMed 38078589American 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.
- Results publication: PubMed 11469709Risk 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.
- Results publication: PubMed 21626897Bosomworth NJ. Practical use of the Framingham risk score in primary prevention: Canadian perspective. Can Fam Physician. 2011 Apr;57(4):417-23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Labiba K. El-Khordagui, Prof. Dr. study director
Alexandria University
Ahmed F. El-Yazbi, Prof. Dr. study director
Alamein International University and Alexandria University
Mohamed I. Sanhoury, Ass. prof. study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hala A. Abo El-Hassan, MSC (002/01114851485, hala.aboelhassan@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beat-to-beat Heart rate variability (time frame: one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06305195, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.