ECG Changes in Children and Adolescents With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

ECG Changes in Children and Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03260998
• Other study ID #: ECGCCATD
• Status: Not yet recruiting
• Phase: N/A
• First received: August 18, 2017
• Last updated: August 27, 2017
• Start date: August 2017
• Est. completion date: January 2019

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Mohamed Amir, MD
• Phone: 01005689353
• Email: Dr.amir63[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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 .

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Diagnostic Test:
• electrocardiogram
measurment of QT dispersion and corrected QT and other electrocardiogram changes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corrected QT dispersion	difference between maximal and minimal corrected QT intervals from different ECG leads	one day