Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes

ConditionsAtherosclerotic Cardiovascular Disease Childhood Diabetes Mellitus Juvenile Diabetes

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorShanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of type 1 diabetes or type 2 diabetes

Age of onset: <18y

Enrollment age: ≥18y

Gender: male or female

Disqualifiers

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

Trial population

Random

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants

are grouped into 2 trial groups

Group A: Type 1 Diabetes

Group B: Type 2 Diabetes

Trial 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

Other outcomes

Glycemic control(glycated hemoglobin)

To study glycemic control by comparing glycated hemoglobin(HbA1c)

Time frame

5 years

Glycemic control(free blood glucose)

To study glycemic control by comparing free blood glucose(FBG)

Time frame

5 years

Glycemic control(postprandial blood glucose)

To study glycemic control by comparing postprandial blood glucose(PBG) with mixed meal tolerance test (MMTT)

Time frame

5 years

Glycemic control(severe hypoglycemia events)

Severe hypoglycemia events in the past six months

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: