Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes

NCT05294653 | Not Yet Recruiting

• 1 other identifier: youngascvd
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Cardiovascular Disease; Childhood Diabetes Mellitus; Juvenile Diabetes

Outcome Measures

Primary Outcomes (1)

• 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)

  5 years

Secondary Outcomes (4)

• Occurrence of subclinical ASCVD(carotid plaque)

  5 years

• Occurrence of subclinical ASCVD(carotid intima-media thickness)

  5 years

• Occurrence of subclinical ASCVD(pulse wave velocity)

  5 years

• Occurrence of subclinical ASCVD(coronary artery calcium)

  5 years

Other Outcomes (18)

• Glycemic control(glycated hemoglobin)

  5 years

• Glycemic control(free blood glucose)

  5 years

• Glycemic control(postprandial blood glucose)

  5 years

Study Arms (2)

Type 1 Diabetes

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

Type 2 Diabetes

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Random

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Atherosclerosis; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Weiqiong Gu, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiqiong Gu, PhD

CONTACT

64370045; weiqionggu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Risk of Atherosclerotic Cardiovascular Disease in Childhood and Teen-age Onset Diabetes

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 24, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

CN (1)