Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes

NCT ID: NCT05294653

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2027-01-01

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.

Conditions

Atherosclerotic Cardiovascular Disease; Childhood Diabetes Mellitus; Juvenile Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Type 1 Diabetes

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

No interventions assigned to this group

Type 2 Diabetes

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Weiqiong Gu

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weiqiong Gu, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Shanghai, , China

Countries

China

Central Contacts

Weiqiong Gu, PhD

Role: CONTACT

weiqionggu@163.com

64370045 ext. 671701

Facility Contacts

Weiqiong Gu, PhD

Role: primary

weiqionggu@163.com

64370045 ext. 672701

Other Identifiers

youngascvd

Identifier Type: -

Identifier Source: org_study_id