Clinical trial NCT05294653: Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes
Official title: Risk of Atherosclerotic Cardiovascular Disease in Childhood and Teen-age Onset Diabetes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atherosclerotic Cardiovascular Disease
Childhood Diabetes Mellitus
Juvenile Diabetes
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Random

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.

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

Primary outcomes:
measure: Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating
timeFrame: 5 years
Secondary outcomes:
measure: Occurrence of subclinical ASCVD(carotid plaque)
timeFrame: 5 years
measure: Occurrence of subclinical ASCVD(carotid intima-media thickness)
timeFrame: 5 years
measure: Occurrence of subclinical ASCVD(pulse wave velocity)
timeFrame: 5 years
measure: Occurrence of subclinical ASCVD(coronary artery calcium)
timeFrame: 5 years
Other outcomes:
measure: Glycemic control(glycated hemoglobin)
timeFrame: 5 years
measure: Glycemic control(free blood glucose)
timeFrame: 5 years
measure: Glycemic control(postprandial blood glucose)
timeFrame: 5 years
measure: Glycemic control(severe hypoglycemia events)
timeFrame: 5 years
measure: Islet function(fasting C peptide)
timeFrame: 5 years
measure: Islet function(2-hour post-meal stimulated C peptide)
timeFrame: 5 years
measure: Islet function(pancreatic enhanced MR)
timeFrame: 5 years
measure: Daily insulin dosage
timeFrame: 5 years
measure: Frequency of daily moderate to high-intensity aerobic exercise
timeFrame: 5 years
measure: Occurrence of diabetic nephropathy
timeFrame: 5 years
measure: Concentration of cardiac troponin T
timeFrame: 5 years
measure: Level of high-sensitivity C-reactive protein
timeFrame: 5 years
measure: Occurrence of diabetic retinopathy
timeFrame: 5 years
measure: Level of cardiac function
timeFrame: 5 years
measure: Occurrence of diabetic neuropathy
timeFrame: 5 years
measure: Level of thyroid hormones
timeFrame: 5 years
measure: Level of free cortisol rhythm
timeFrame: 5 years
measure: Occurrence of rheumatic diseases
timeFrame: 5 years
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University
Study officials:
affiliation: Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University
name: Weiqiong Gu, PhD
role: PRINCIPAL_INVESTIGATOR
References: