ClinicalTrials.gg
CompletedNCT06356051Updated Apr 10, 2024

Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus

An observational study in Type 1 Diabetes, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
202
Ages
8 Years to 18 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Type 1 Diabetes
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In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 202 is above the median of 121 across 769 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 437 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

type 1 diabetes mellitus and age and gender mathced healthy children

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
202 participants (actual)
Patient registry
No

Groups and cohorts

  • Type1 diabetes mellitus

    Device: Echocardiography

  • Healthy children

    Device: Echocardiography

Interventions

  • DeviceEchocardiography

    cardiovascular evaluation

    Also known as: oscillometric Mobil-O-Graph device

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What researchers measure

Primary outcomes

  1. Epicardial fat thickness

    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.

    Time frame: january 2023-june 2023

Secondary outcomes

  1. carotid intima-media thickness

    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.

    Time frame: january 2023-june 2023

  2. arterial stiffness parameters such as pulse wave velocity, augmentation index

    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.

    Time frame: january 2023-june 2023

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Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, Turkey (Türkiye)
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References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 4, 2023

Documents are hosted by the registry — open the source record to download them.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Jun 2023, 5 months.

Of 239 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's 5 months is below that.

Counting every sponsor, half of 288 studies reached it within 27 months; a quarter within 12 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2024
First posted
Apr 10, 2024
StartActual
Jan 1, 2023
Primary completionActual
Jun 1, 2023
CompletionActual
Sep 1, 2023
Last update
Apr 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06356051
Responsible party
Sponsor
First posted
Apr 10, 2024
Start date
Jan 1, 2023
Primary completion
Jun 1, 2023
Completion
Sep 1, 2023
Last update
Apr 10, 2024

Oversight

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

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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