ECG Changes in Children and Adolescents With Type 1 Diabetes
1 other identifier
observational
120
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedAugust 29, 2017
August 1, 2017
1 year
August 18, 2017
August 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
corrected QT dispersion
difference between maximal and minimal corrected QT intervals from different ECG leads
one day
Study Arms (2)
diabetic patients type 1
electrocardiogram will be done for 60 children and adolescents with type 1 diabetes
healthy persons
electrocardiogram will be done for 60 age and sex matched non diabetic children and adolescents
Interventions
measurment of QT dispersion and corrected QT and other electrocardiogram changes
Eligibility Criteria
The study will include 60 children and adolescents with type 1 diabetes attending Assiut university hospital and 60 sex and age matched control subjects .
You may qualify if:
- All children and adolescents with type 1 diabetes
You may not qualify if:
- Cornary artery disease .
- Heart failure , congenital heart disease ,
- Rheumatic valve disease .
- Primary cardiomyopathy .
- Thyroid dysfunction .
- Bundle branch block and atrioventricular conduction abnormalities .
- Anti arrhythmic drugs .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariam Atef, master
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
August 18, 2017
First Posted
August 24, 2017
Study Start
August 1, 2017
Primary Completion
August 1, 2018
Study Completion
January 1, 2019
Last Updated
August 29, 2017
Record last verified: 2017-08