Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes

N/ANot Yet RecruitingNCT05294653

Shanghai Jiao Tong University School of Medicine300 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Atherosclerotic Cardiovascular Disease Childhood Diabetes Mellitus Juvenile Diabetes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University

Shanghai, China

Outcomes

Primary Outcomes

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)

Time frame: 5 years

Secondary Outcomes

Occurrence of subclinical ASCVD(carotid plaque)

Carotid plaque(IMT\>1.5mm)

Time frame: 5 years

Occurrence of subclinical ASCVD(carotid intima-media thickness)

Carotid intima-media thickness(CIMT)≥0.9mm

Time frame: 5 years

Occurrence of subclinical ASCVD(pulse wave velocity)

Pulse wave velocity(PWV)\>6.8m/s

Time frame: 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)

Time frame: 5 years

Central Contacts

Weiqiong Gu, PhD

CONTACT

64370045 weiqionggu@163.com

Data from ClinicalTrials.gov

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