Cardiac Autonomic NeuropathyNCT07613372
Evaluation of Cardiac Autonomic Neuropathy in Children and Adolescents With Type 1 Diabetes Mellitus
A study testing Holter in people with Cardiac Autonomic Neuropathy and Diabete Type 1, run by Marwa Abouelela Abd Elsalam at 1 site in Egypt.
Trial summary
study is to evaluate the prevalence of cardiac autonomic neuropathy in children with Type 1 DM and correlation with duration of DM and glycemic control. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cardiac Autonomic Neuropathy, Diabete Type 1, Pediatrics
- What is being tested?
- Holter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≤18 years old Both males and females will be included. Patients diagnosed with type 1 DM for a duration ≥ 5 y. Both well controlled and poorly controlled patients will be included.
Who cannot join
- Patients with diabetes other than Type 1 DM. Coexisting medical conditions such as thyroid disorders, celiac disease, epilepsy, or chronic pulmonary or hepatic disease.
- Known cardiac conditions, including congenital heart disease, cardiomyopathy, conduction disorders, or previous cardiac surgery.
- Acute illness at the time of evaluation or history of diabetic ketoacidosis within the preceding 3 months.
- Use of medications affecting heart rate or rhythm, including beta-blockers, theophylline, or levothyroxine
Trial locations and contacts
1 site in 1 country.
About this study
study is to evaluate the prevalence of cardiac autonomic neuropathy in children with Type 1 DM and correlation with duration of DM and glycemic control.
- Conditions
- Cardiac Autonomic Neuropathy, Diabete Type 1, Pediatrics
- Being tested
- Holter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HolterDevice
Baseline Electrocardiogram (ECG) Cardiac Autonomic Reflex Tests (CARTs)
| Study group | Role | What they receive |
|---|---|---|
| Case Group 1-A | Experimental | evaluation of autonomic cardiac neuropathy using 24 hrs rhythm Holter and Cardiac Autonomic Reflex Tests (CARTs) in children and adolescent with type 1 DM for 5 - 10 years Receives: Device: Holter |
| Case Group 1-B | Experimental | evaluation of autonomic cardiac neuropathy using 24 hrs rhythm Holter and Cardiac Autonomic Reflex Tests (CARTs) in children and adolescent with type 1 DM more than 10 years Receives: Device: Holter |
| Control Group (Group 2) | Experimental | evaluation of autonomic cardiac neuropathy using 24 hrs rhythm Holter and Cardiac Autonomic Reflex Tests (CARTs) in children and adolescent in healthy children Receives: Device: Holter |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the prevalence of cardiac autonomic neuropathy in children with Type 1 DM and correlation with duration of DM and glycemic control.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Autonomic NeuropathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marwa Abouelela Abd Elsalam
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Marwa Abouelela Abd Elsalam, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613372
- Sponsor's protocol ID
- 36265MD41032/2/26
- Status last verified
- Feb 2026
- First submitted
- 18 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data will be available upon a reasonable request from the corresponding author after the end of the study for one year
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Autonomic Neuropathy in Children and Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07613372
- Acronym / sponsor ID
- 36265MD41032/2/26
- Conditions
- Cardiac Autonomic Neuropathy, Diabete Type 1, Pediatrics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Marwa Abouelela Abd ElsalamUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 29 May 2026 (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.
study is to evaluate the prevalence of cardiac autonomic neuropathy in children with Type 1 DM and correlation with duration of DM and glycemic control.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case Group 1-A | Experimental | Device: Holterevaluation of autonomic cardiac neuropathy using 24 hrs rhythm Holter and Cardiac Autonomic Reflex Tests (CARTs) in children and adolescent with type 1 DM for 5 - 10 years |
| Case Group 1-B | Experimental | Device: Holterevaluation of autonomic cardiac neuropathy using 24 hrs rhythm Holter and Cardiac Autonomic Reflex Tests (CARTs) in children and adolescent with type 1 DM more than 10 years |
| Control Group (Group 2) | Experimental | Device: Holterevaluation of autonomic cardiac neuropathy using 24 hrs rhythm Holter and Cardiac Autonomic Reflex Tests (CARTs) in children and adolescent in healthy children |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age ≤18 years old Both males and females will be included. Patients diagnosed with type 1 DM for a duration ≥ 5 y. Both well controlled and poorly controlled patients will be included.
Key exclusion criteria (4 listed)
- Patients with diabetes other than Type 1 DM. Coexisting medical conditions such as thyroid disorders, celiac disease, epilepsy, or chronic pulmonary or hepatic disease.
- Known cardiac conditions, including congenital heart disease, cardiomyopathy, conduction disorders, or previous cardiac surgery.
- Acute illness at the time of evaluation or history of diabetic ketoacidosis within the preceding 3 months.
- Use of medications affecting heart rate or rhythm, including beta-blockers, theophylline, or levothyroxine
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 |
|---|---|---|
| HolterBaseline Electrocardiogram (ECG) Cardiac Autonomic Reflex Tests (CARTs) | Device | Case Group 1-A, Case Group 1-B, Control Group (Group 2) |
Primary outcome
evaluate the prevalence of cardiac autonomic neuropathy in children with Type 1 DM and correlation with duration of DM and glycemic control.
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes. the data will be available upon a reasonable request from the corresponding author after the end of the study for one year
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The Effect of Autonomic Neuropathy Status on the Endpoint Events in Diabetes Patients With Coronary Heart Disease and Sleep Apnea.
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The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holter in people with Cardiac Autonomic Neuropathy and Diabete Type 1, run by Marwa Abouelela Abd Elsalam 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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the prevalence of cardiac autonomic neuropathy in children with Type 1 DM and correlation with duration of DM and glycemic control. (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.