ECG Changes in Children and Adolescents With Type 1 Diabetes

NCT ID: NCT03260998

Last Updated: 2017-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-31

Study Completion Date

2019-01-31

Brief Summary

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Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of diabetes mellitus during childhood and adolescence. Hyperglycemia is a major cause of vascular and neuropathic complications that are seen in patients with diabetes mellitus type 1.

Detailed Description

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Cardiovascular risk factors remain the most controversial chronic complication in diabetes mellitus type 1 Neuropathy in diabetes mellitus type 1 can lead to abnormalities in the response of the coronary vasculature to sympathetic stimulation, which may manifest clinically as resting tachycardia or bradycardia, exercise intolerance, orthostatic hypotension, loss of the nocturnal decline in blood pressure, or silent myocardial ischemia on cardiac testing. These abnormalities can lead to delayed presentation of cardiovascular disease. An early indicator of cardiac autonomic neuropathy is reduced heart rate variability, which can be assessed qualitatively in the clinic. Limited data suggest silent myocardial ischemia is more common in the presence of cardiac autonomic neuropathy . Cardiovascular mortality is a leading cause of death in Type 1 diabetic patients, in particular in patients with nephropathy.QT dispersion defined as the difference between maximal and minimal QT intervals from different electrocardiogram leads ( the QT interval was defined as the time between the first deflection from the isoelectric PR interval and the visual return of the T wave to the T-P segment ) ,Because these electrocardiogram abnormalities may confer an increased risk of ventricular arrhythmias and sudden cardiac death , early identification may have prognostic value .

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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diabetic patients type 1

electrocardiogram will be done for 60 children and adolescents with type 1 diabetes

electrocardiogram

Intervention Type DIAGNOSTIC_TEST

measurment of QT dispersion and corrected QT and other electrocardiogram changes

healthy persons

electrocardiogram will be done for 60 age and sex matched non diabetic children and adolescents

electrocardiogram

Intervention Type DIAGNOSTIC_TEST

measurment of QT dispersion and corrected QT and other electrocardiogram changes

Interventions

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electrocardiogram

measurment of QT dispersion and corrected QT and other electrocardiogram changes

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All children and adolescents with type 1 diabetes

Exclusion Criteria

1. Cornary artery disease .
2. Heart failure , congenital heart disease ,
3. Rheumatic valve disease .
4. Primary cardiomyopathy .
5. Thyroid dysfunction .
6. Bundle branch block and atrioventricular conduction abnormalities .
7. Anti arrhythmic drugs .
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Nagieb

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariam Atef, master

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Mohamed Amir, MD

Role: CONTACT

01005689353

Ameer Abo Elgheet, MD

Role: CONTACT

01065742277

Other Identifiers

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ECGCCATD

Identifier Type: -

Identifier Source: org_study_id

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