Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Risk of Atherosclerotic Cardiovascular Disease in Childhood and Teen-age Onset Diabetes

Conditions
-----------------
Atherosclerotic Cardiovascular Disease, Childhood Diabetes Mellitus, Juvenile Diabetes

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 Diabetes<br>Classified according to American Diabetes Association [ADA] 2021 guidelines | |
| Type 2 Diabetes<br>Classified according to American Diabetes Association [ADA] 2021 guidelines | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of subclinical ASCVD(carotid plaque) | Carotid plaque(IMT>1.5mm) | 5 years | 
| Occurrence of subclinical ASCVD(carotid intima-media thickness) | Carotid intima-media thickness(CIMT)≥0.9mm | 5 years | 
| Occurrence of subclinical ASCVD(pulse wave velocity) | Pulse wave velocity(PWV)>6.8m/s | 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) | 5 years |