Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus

April 2, 2024 updated by: Ankara City Hospital Bilkent

Evaluation of Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus by Oscillometric Method and Echocardiography

Epicardial fat thickness, carotid intima-media thickness, and augmentation index from arterial stiffness indicators are increased in children with T1DM compared to the healthy control group. These results support the idea that children with T1DM present significant changes in important subclinical indicators for the development of cardiovascular disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

type 1 diabetes mellitus and age and gender mathced healthy children

Description

Inclusion Criteria:

  1. type T1DM patients
  2. body mass index (BMI) between the 5th and 85th percentile according to age and gender
  3. having T1DM for at least 2 years
  4. ages 8-18 years

Exclusion Criteria:

  1. having any chronic diseases other than T1DM
  2. presence of a congenital and/or acquired heart disease, hypertension etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy children
Device: Echocardiography
cardiovascular evaluation
Other Names:
  • oscillometric Mobil-O-Graph device
Type1 diabetes mellitus
Device: Echocardiography
cardiovascular evaluation
Other Names:
  • oscillometric Mobil-O-Graph device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epicardial fat thickness
Time Frame: january 2023-june 2023
Epicardial fat thickness was measured with Echocardiography as milimeter. Epicardial fat was identified as the echo-free space between the outer wall of the myocardium and the visceral layer of pericardium. The values of children with type 1 DM were compared with healthy children. Values are given as mean and standard deviation.
january 2023-june 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
carotid intima-media thickness
Time Frame: january 2023-june 2023
carotid intima-media thickness were measured by echocardiography machine as milimeter. cIMT is defined as the distance between the first echogenic line (lumen-intima interface) and the second echogenic line (media-adventitia interface) of the far wall. The values of children with type 1 DM were compared with healthy children. Values are given as mean and standard deviation.
january 2023-june 2023
arterial stiffness parameters such as pulse wave velocity, augmentation index
Time Frame: january 2023-june 2023
cuff-based validated oscillometric Mobil-O-Graph device (I.E.M., GmbH, Aachen, Germany) was used to these parameters. Data from the Mobil-O Graph device was exported and analyzed using Hypertension Management Software Client-Server version 5.2.3. The values of children with type 1 DM were compared with healthy children. Values are given as mean and standard deviation.
january 2023-june 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gbuyukyilmaz

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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