Type 1 DiabetesNCT06356051
Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus
An observational study of Type 1 Diabetes, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- How many people
- 202 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: type 1 diabetes mellitus and age and gender mathced healthy children
Who may be able to join
- type T1DM patients
- body mass index (BMI) between the 5th and 85th percentile according to age and gender
- having T1DM for at least 2 years
- ages 8-18 years
Who cannot join
- having any chronic diseases other than T1DM
- presence of a congenital and/or acquired heart disease, hypertension etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Echocardiography
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
Also called oscillometric Mobil-O-Graph device
cardiovascular evaluation
| Study group | Role | What they receive |
|---|---|---|
| Type1 diabetes mellitus | Not described Receives: Device: Echocardiography | |
| Healthy children | Not described Receives: Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: january 2023-june 2023
Secondary outcomes (2)
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.
Measured: january 2023-june 2023
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.
Measured: january 2023-june 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356051
- Sponsor's protocol ID
- Gbuyukyilmaz
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus by Oscillometric Method and Echocardiography
- ClinicalTrials.gov ID
- NCT06356051
- Acronym / sponsor ID
- Gbuyukyilmaz
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type1 diabetes mellitus | – | Device: Echocardiography |
| Healthy children | – | Device: Echocardiography |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- type 1 diabetes mellitus and age and gender mathced healthy children
Key inclusion criteria (4 listed)
- type T1DM patients
- body mass index (BMI) between the 5th and 85th percentile according to age and gender
- having T1DM for at least 2 years
- ages 8-18 years
Key exclusion criteria (2 listed)
- having any chronic diseases other than T1DM
- presence of a congenital and/or acquired heart disease, hypertension etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyAlso: oscillometric Mobil-O-Graph devicecardiovascular evaluation | Device | Healthy children, Type1 diabetes mellitus |
Primary outcome
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.
2 secondary outcomes
carotid intima-media thickness
Time frame: january 2023-june 2023
arterial stiffness parameters such as pulse wave velocity, augmentation index
Time frame: january 2023-june 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial fat thickness (time frame: january 2023-june 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.