Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes

Shanghai Jiao Tong University School of Medicine

Status: Not yet enrolling

Conditions: Childhood Diabetes Mellitus; Atherosclerotic Cardiovascular Disease; Juvenile Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT05294653

youngascvd

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of type 1 diabetes or type 2 diabetes
2. Age of onset: <18y
3. Enrollment age: ≥18y
4. Gender: male or female
5. Diabetes duration ≥ 5 years

Exclusion criteria

1. Specific types of diabetes
2. Clinical diagnosis of diabetes is unknown, and it belongs to untyped diabetes
3. Pregnancy or lactation
4. 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
5. Onset of acute complications of diabetes in the past 3 months
6. Major trauma and surgery history in the past 3 months

Trial design

300 participants in 2 patient groups

Type 1 Diabetes

Description:

Classified according to American Diabetes Association \[ADA\] 2021 guidelines

Type 2 Diabetes

Description:

Classified according to American Diabetes Association \[ADA\] 2021 guidelines