Atherosclerotic Cardiovascular DiseaseNCT05294653
Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes
An observational study of Atherosclerotic Cardiovascular Disease and Childhood Diabetes Mellitus, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
For children and adolescents with diabetes, the pathological process of atherosclerotic cardiovascular disease(ASCVD) can exist in early childhood and progress rapidly to subclinical ASCVD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, Childhood Diabetes Mellitus, Juvenile Diabetes
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Random
Who may be able to join
- Diagnosis of type 1 diabetes or type 2 diabetes
- Age of onset: <18y
- Enrollment age: ≥18y
- Gender: male or female
- Diabetes duration ≥ 5 years
Who cannot join
- Specific types of diabetes
- Clinical diagnosis of diabetes is unknown, and it belongs to untyped diabetes
- Pregnancy or lactation
- Received glucocorticoids, immunosuppressants, non-glycemic biological agents, and cytotoxic drugs in the past 3 months; non-steroidal pain relievers or antibiotics used for more than 1 week continuously
- Onset of acute complications of diabetes in the past 3 months
- Major trauma and surgery history in the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University
Shanghai, 200025
Weiqiong Gu, PhD, 64370045 ext. 672701, weiqionggu@163.com
About this study
Official title: Risk of Atherosclerotic Cardiovascular Disease in Childhood and Teen-age Onset Diabetes
For children and adolescents with diabetes, the pathological process of atherosclerotic cardiovascular disease(ASCVD) can exist in early childhood and progress rapidly to subclinical ASCVD. This study intends to explore the models for the prediction of ASCVD risk in childhood and teen-age onset diabetes with different types.
Read the detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the main cause of death in patients with diabetes. Currently recognized ASCVD risk assessment models are limited to adults with diabetes, but for children and adolescents with diabetes, the pathological process of ASCVD can exist in early childhood and progress rapidly to subclinical ASCVD.
To sum up, this study intends to evaluate the high risk rate of ASCVD calculated by the traditional QRISK3 model and its correlation with the occurrence of subclinical ASCVD events through long-term follow-up of the natural history of diabetes onset in children and adolescents, and to explore the models for the prediction of ASCVD risk in childhood and teen-age onset diabetes with different types. This study aims to help block the pathological process of ASCVD in early duration, thereby reducing the occurrence of ASCVD in childhood and teen-age onset diabetes.
- Medical subject headings
- Atherosclerosis, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes | Classified according to American Diabetes Association [ADA] 2021 guidelines | |
| Type 2 Diabetes | Classified according to American Diabetes Association [ADA] 2021 guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating
Risk value calculated by QRISK3 model >10% (The QRISK®3-2018 risk calculator https://qrisk.org/three)
Measured: 5 years
Secondary outcomes (4)
Occurrence of subclinical ASCVD(carotid plaque)
Carotid plaque(IMT>1.5mm)
Measured: 5 years
Occurrence of subclinical ASCVD(carotid intima-media thickness)
Carotid intima-media thickness(CIMT)≥0.9mm
Measured: 5 years
Occurrence of subclinical ASCVD(pulse wave velocity)
Pulse wave velocity(PWV)>6.8m/s
Measured: 5 years
Occurrence of subclinical ASCVD(coronary artery calcium)
Coronary artery calcium(CAC) score>0 (CAC:assessed only when subclinical ASCVD events confirmed by IMT, CIMT, PWV)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiqiong Gu, Shanghai Jiao Tong University School of Medicine
- Investigators
- Weiqiong Gu, PhD, Principal investigator, Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294653
- Sponsor's protocol ID
- youngascvd
- Status last verified
- May 2022
- First submitted
- 25 Feb 2022
- Last updated
- 23 May 2022
- 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 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Atherosclerotic Cardiovascular Disease in Childhood and Teen-age Onset Diabetes
- ClinicalTrials.gov ID
- NCT05294653
- Acronym / sponsor ID
- youngascvd
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 Mar 2022 (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.
For children and adolescents with diabetes, the pathological process of atherosclerotic cardiovascular disease(ASCVD) can exist in early childhood and progress rapidly to subclinical ASCVD. This study intends to explore the models for the prediction of ASCVD risk in childhood and teen-age onset diabetes with different types.
Detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the main cause of death in patients with diabetes. Currently recognized ASCVD risk assessment models are limited to adults with diabetes, but for children and adolescents with diabetes, the pathological process of ASCVD can exist in early childhood and progress rapidly to subclinical ASCVD.
To sum up, this study intends to evaluate the high risk rate of ASCVD calculated by the traditional QRISK3 model and its correlation with the occurrence of subclinical ASCVD events through long-term follow-up of the natural history of diabetes onset in children and adolescents, and to explore the models for the prediction of ASCVD risk in childhood and teen-age onset diabetes with different types. This study aims to help block the pathological process of ASCVD in early duration, thereby reducing the occurrence of ASCVD in childhood and teen-age onset diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes | – | –Classified according to American Diabetes Association [ADA] 2021 guidelines |
| Type 2 Diabetes | – | –Classified according to American Diabetes Association [ADA] 2021 guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Random
Key inclusion criteria (5 listed)
- Diagnosis of type 1 diabetes or type 2 diabetes
- Age of onset: <18y
- Enrollment age: ≥18y
- Gender: male or female
- Diabetes duration ≥ 5 years
Key exclusion criteria (6 listed)
- Specific types of diabetes
- Clinical diagnosis of diabetes is unknown, and it belongs to untyped diabetes
- Pregnancy or lactation
- Received glucocorticoids, immunosuppressants, non-glycemic biological agents, and cytotoxic drugs in the past 3 months; non-steroidal pain relievers or antibiotics used for more than 1 week continuously
- Onset of acute complications of diabetes in the past 3 months
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
Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating
Time frame: 5 years
Risk value calculated by QRISK3 model >10% (The QRISK®3-2018 risk calculator https://qrisk.org/three)
4 secondary outcomes
Occurrence of subclinical ASCVD(carotid plaque)
Time frame: 5 years
Occurrence of subclinical ASCVD(carotid intima-media thickness)
Time frame: 5 years
Occurrence of subclinical ASCVD(pulse wave velocity)
Time frame: 5 years
Occurrence of subclinical ASCVD(coronary artery calcium)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
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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.
Weiqiong Gu, PhD principal investigator
Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University
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 Atherosclerotic Cardiovascular Disease and Childhood Diabetes Mellitus, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 23 May 2022. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiqiong Gu, PhD (64370045 ext. 671701, weiqionggu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating (time frame: 5 years). 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 23 May 2022.