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Clinical Trials/NCT05294653
NCT05294653
Not yet recruiting
Not Applicable

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

Shanghai Jiao Tong University School of Medicine1 site in 1 country300 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atherosclerotic Cardiovascular Disease
Sponsor
Shanghai Jiao Tong University School of Medicine
Enrollment
300
Locations
1
Primary Endpoint
Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating
Status
Not yet recruiting
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
January 1, 2027
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Weiqiong Gu

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

Shanghai Jiao Tong University School of Medicine

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

Outcomes

Primary Outcomes

Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating

Time Frame: 5 years

Risk value calculated by QRISK3 model \>10% (The QRISK®3-2018 risk calculator https://qrisk.org/three)

Secondary Outcomes

  • Occurrence of subclinical ASCVD(carotid intima-media thickness)(5 years)
  • Occurrence of subclinical ASCVD(coronary artery calcium)(5 years)
  • Occurrence of subclinical ASCVD(carotid plaque)(5 years)
  • Occurrence of subclinical ASCVD(pulse wave velocity)(5 years)

Study Sites (1)

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