Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

ECG Changes in Children and Adolescents With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03260998
Recruitment Status : Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Mariam Nagieb, Assiut University

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Diagnostic Test: electrocardiogram

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 .

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: ECG Changes in Children and Adolescents With Type 1 Diabetes
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
diabetic patients type 1
electrocardiogram will be done for 60 children and adolescents with type 1 diabetes
Diagnostic Test: electrocardiogram
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
Diagnostic Test: electrocardiogram
measurment of QT dispersion and corrected QT and other electrocardiogram changes




Primary Outcome Measures :
  1. corrected QT dispersion [ Time Frame: one day ]
    difference between maximal and minimal corrected QT intervals from different ECG leads



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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 .
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260998


Contacts
Layout table for location contacts
Contact: Mohamed Amir, MD 01005689353 Dr.amir63@yahoo.com
Contact: Ameer Abo Elgheet, MD 01065742277 Dr.amir63@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Principal Investigator: Mariam Atef, master Assiut University

Layout table for additonal information
Responsible Party: Mariam Nagieb, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03260998     History of Changes
Other Study ID Numbers: ECGCCATD
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases