Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus

NCT ID: NCT06356051

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Type1 diabetes mellitus

Echocardiography

Intervention Type DEVICE

cardiovascular evaluation

Healthy children

Echocardiography

Intervention Type DEVICE

cardiovascular evaluation

Interventions

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Echocardiography

cardiovascular evaluation

Intervention Type DEVICE

Other Intervention Names

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oscillometric Mobil-O-Graph device

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Gbuyukyilmaz

Identifier Type: -

Identifier Source: org_study_id

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