Type1 Diabetes MellitusNCT03544541
Cardiometabolic Risk in Children With Type 1 Diabetes.
An observational study of Type1 Diabetes Mellitus and Metabolic Complication, run by University of Ljubljana, Faculty of Medicine at 1 site in Slovenia.
Trial summary
To access the relationship between metabolic control of children and adolescents with type 1 diabetes and cardiometabolic risk through noninvasive imaging modalities to assess the early vasculature changes. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Type1 Diabetes Mellitus, Metabolic Complication
- How many people
- 150 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 Jan 2018to 30 Nov 2019
- How long will I take part?
- 2 Years
- 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 10 to 25 years
- All sexes
- Child, Adult
Study population: Nationwide cohort of children and adolescents with type 1 diabetes
Who may be able to join
- Type 1 diabetes for more than 0.5 year
- Age ≥ 10 years up to 25 years (inclusive)
- The subject/carer is willing to follow study specific instructions
Who cannot join
- Youth with maturity-onset diabetes of the young, hybrid, other, or missing type
- Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study
- Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Metabolic Control and Cardiometabolic Risk in Children With Type 1 Diabetes.
To access the relationship between metabolic control of children and adolescents with type 1 diabetes and cardiometabolic risk through noninvasive imaging modalities to assess the early vasculature changes.
- Conditions
- Type1 Diabetes Mellitus, Metabolic Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Intima-Media Thickness
Non-invasive (Doppler Ultrasound) measurement of Carotid Intima-Media Thickness
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start5 Jan 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Ljubljana, Faculty of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544541
- Sponsor's protocol ID
- Cardio-Risk-T1D-SI
- Status last verified
- Nov 2019
- First submitted
- 27 Feb 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Metabolic Control and Cardiometabolic Risk in Children With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT03544541
- Acronym / sponsor ID
- Cardio-Risk-T1D-SI
- Conditions
- Type1 Diabetes Mellitus, Metabolic Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Ljubljana, Faculty of MedicineUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 1 Jun 2018 (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.
To access the relationship between metabolic control of children and adolescents with type 1 diabetes and cardiometabolic risk through noninvasive imaging modalities to assess the early vasculature changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Nationwide cohort of children and adolescents with type 1 diabetes
Key inclusion criteria (3 listed)
- Type 1 diabetes for more than 0.5 year
- Age ≥ 10 years up to 25 years (inclusive)
- The subject/carer is willing to follow study specific instructions
Key exclusion criteria (3 listed)
- Youth with maturity-onset diabetes of the young, hybrid, other, or missing type
- Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study
- Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Carotid Intima-Media Thickness
Time frame: 24 months
Non-invasive (Doppler Ultrasound) measurement of Carotid Intima-Media Thickness
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 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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 Type1 Diabetes Mellitus and Metabolic Complication, run by University of Ljubljana, Faculty of Medicine at 1 site in Slovenia.
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 3 inclusion and 3 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 5 Feb 2020. 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 Slovenia. 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?
Carotid Intima-Media Thickness (time frame: 24 months). 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 5 Feb 2020.