Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atherosclerotic Cardiovascular Disease, Childhood Diabetes Mellitus, Juvenile Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risk of Atherosclerotic Cardiovascular Disease in Childhood and Teen-age Onset Diabetes
Overview
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.
Primary outcome measures
- Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating [Time frame: 5 years]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- Diagnosis of type 1 diabetes or type 2 diabetes
- Age of onset: <18y
- Enrollment age: ≥18y
- Gender: male or female
- Diabetes duration ≥ 5 years
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong Un — Shanghai
Identifiers
NCT: NCT05294653 · youngascvd