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Status unknownNCT03260998Updated Aug 29, 2017

ECG Changes in Children and Adolescents With Type 1 Diabetes

An observational study in Diabetes Mellitus, Type 1, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2017-08-29.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Sex
All
01

Study 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.

Read the detailed 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 .

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Conditions studied

  • Diabetes Mellitus, Type 1
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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study will include 60 children and adolescents with type 1 diabetes attending Assiut university hospital and 60 sex and age matched control subjects .

Inclusion criteria

  • All children and adolescents with type 1 diabetes

Exclusion criteria

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 .
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • diabetic patients type 1

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

    Diagnostic Test: electrocardiogram

  • healthy persons

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

    Diagnostic Test: electrocardiogram

Interventions

  • Diagnostic testelectrocardiogram

    measurment of QT dispersion and corrected QT and other electrocardiogram changes

05

What researchers measure

Primary outcomes

  1. corrected QT dispersion

    difference between maximal and minimal corrected QT intervals from different ECG leads

    Time frame: one day

06

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03260998
Lead sponsor
Assiut University
Responsible party
Mariam Nagieb (principal investigator, Assiut University) — Principal investigator
First posted
Aug 24, 2017
Start date
Aug 2017 (estimated)
Primary completion
Aug 2018 (estimated)
Completion
Jan 2019 (estimated)
Last update
Aug 29, 2017

Study contacts

Mohamed Amir, MD
Contact
Dr.amir63@yahoo.com
01005689353
Ameer Abo Elgheet, MD
Contact
Dr.amir63@yahoo.com
01065742277
Mariam Atef, master
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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