Atherosclerotic Cardiovascular Disease, Childhood Diabetes Mellitus, Juvenile Diabetes
Conditions
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.
Interventions
None listed
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating | 5 years | Risk value calculated by QRISK3 model \>10% (The QRISK®3-2018 risk calculator https://qrisk.org/three) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of subclinical ASCVD(carotid intima-media thickness) | 5 years | Carotid intima-media thickness(CIMT)≥0.9mm |
| Occurrence of subclinical ASCVD(carotid plaque) | 5 years | Carotid plaque(IMT\>1.5mm) |
| Occurrence of subclinical ASCVD(pulse wave velocity) | 5 years | Pulse wave velocity(PWV)\>6.8m/s |
| Occurrence of subclinical ASCVD(coronary artery calcium) | 5 years | Coronary artery calcium(CAC) score\>0 (CAC:assessed only when subclinical ASCVD events confirmed by IMT, CIMT, PWV) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Islet function(2-hour post-meal stimulated C peptide) | 5 years | To study the residual β-cell function by using 2-hour post-meal stimulated C peptide (PCP) with MMTT |
| Islet function(pancreatic enhanced MR) | 5 years | Volume of the pancreas(ml) calculated by pancreatic enhanced MR |
| Daily insulin dosage | 5 years | To study the insulin requirement by using daily insulin dosage per body weight (DID IU/kg.d) |
| Frequency of daily moderate to high-intensity aerobic exercise | 5 years | To assess the influence of exercise by measuring the frequency of daily moderate to high-intensity aerobic exercise (\<60min, ≥60min) \[pulse=(220-age)\*(60-75%)\] |
| Occurrence of diabetic nephropathy | 5 years | Urine microalbumin (MA)/creatinine (Cr) ratio |
| Concentration of cardiac troponin T | 5 years | To assess the myocardial function by cardiac troponin T(cTnI) |
| Glycemic control(glycated hemoglobin) | 5 years | To study glycemic control by comparing glycated hemoglobin(HbA1c) |
| Occurrence of diabetic retinopathy | 5 years | Retinal photography |
| Level of cardiac function | 5 years | Echocardiography |
| Occurrence of diabetic neuropathy | 5 years | Electrophysiological testing |
| Level of thyroid hormones | 5 years | To assess the occurrence of thyroiditis by thyroid function including triiodothyronine, tetraiodothyronine, thyroid stimulating hormone and thyroid autoantibodies |
| Level of free cortisol rhythm | 5 years | To assess the function of adrenal gland by measuring the level of free cortisol rhythm |
| Occurrence of rheumatic diseases | 5 years | Rheumatic antibody |
| Level of high-sensitivity C-reactive protein | 5 years | To assess the extent of inflammation by high-sensitivity C-reactive protein (hs-CRP) |
| Glycemic control(free blood glucose) | 5 years | To study glycemic control by comparing free blood glucose(FBG) |
| Glycemic control(postprandial blood glucose) | 5 years | To study glycemic control by comparing postprandial blood glucose(PBG) with mixed meal tolerance test (MMTT) |
| Glycemic control(severe hypoglycemia events) | 5 years | Severe hypoglycemia events in the past six months |
| Islet function(fasting C peptide) | 5 years | To study the residual β-cell function by using fasting C peptide(FCP) |
Countries
China
Contacts
Primary ContactWeiqiong Gu, PhD
Outcome results
None listed