Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes

Not yet recruiting

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

• Registration Number: NCT05294653
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-23
• Study Start: 2022-06-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating	5 years	Risk value calculated by QRISK3 model \>10% (The QRISK®3-2018 risk calculator https://qrisk.org/three)

Secondary Outcome Measures

Name	Time	Method
Occurrence of subclinical ASCVD(carotid intima-media thickness)	5 years	Carotid intima-media thickness(CIMT)≥0.9mm
Occurrence of subclinical ASCVD(coronary artery calcium)	5 years	Coronary artery calcium(CAC) score\>0 (CAC:assessed only when subclinical ASCVD events confirmed by IMT, CIMT, PWV)
Occurrence of subclinical ASCVD(carotid plaque)	5 years	Carotid plaque(IMT\>1.5mm)
Occurrence of subclinical ASCVD(pulse wave velocity)	5 years	Pulse wave velocity(PWV)\>6.8m/s

Trial Locations

Locations (1)

Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University; 🇨🇳 Shanghai, China