Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes

Atherosclerotic Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05294653
• Other study ID #: youngascvd
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: May 2022
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Weiqiong Gu, PhD
• Phone: 64370045
• Email: weiqionggu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Childhood Diabetes Mellitus
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Juvenile Diabetes

Locations

Country	Name	City	State
China	Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glycemic control(glycated hemoglobin)	To study glycemic control by comparing glycated hemoglobin(HbA1c)	5 years
Other	Glycemic control(free blood glucose)	To study glycemic control by comparing free blood glucose(FBG)	5 years
Other	Glycemic control(postprandial blood glucose)	To study glycemic control by comparing postprandial blood glucose(PBG) with mixed meal tolerance test (MMTT)	5 years
Other	Glycemic control(severe hypoglycemia events)	Severe hypoglycemia events in the past six months	5 years
Other	Islet function(fasting C peptide)	To study the residual ß-cell function by using fasting C peptide(FCP)	5 years
Other	Islet function(2-hour post-meal stimulated C peptide)	To study the residual ß-cell function by using 2-hour post-meal stimulated C peptide (PCP) with MMTT	5 years
Other	Islet function(pancreatic enhanced MR)	Volume of the pancreas(ml) calculated by pancreatic enhanced MR	5 years
Other	Daily insulin dosage	To study the insulin requirement by using daily insulin dosage per body weight (DID IU/kg.d)	5 years
Other	Frequency of daily moderate to high-intensity aerobic exercise	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%)]	5 years
Other	Occurrence of diabetic nephropathy	Urine microalbumin (MA)/creatinine (Cr) ratio	5 years
Other	Concentration of cardiac troponin T	To assess the myocardial function by cardiac troponin T(cTnI)	5 years
Other	Level of high-sensitivity C-reactive protein	To assess the extent of inflammation by high-sensitivity C-reactive protein (hs-CRP)	5 years
Other	Occurrence of diabetic retinopathy	Retinal photography	5 years
Other	Level of cardiac function	Echocardiography	5 years
Other	Occurrence of diabetic neuropathy	Electrophysiological testing	5 years
Other	Level of thyroid hormones	To assess the occurrence of thyroiditis by thyroid function including triiodothyronine, tetraiodothyronine, thyroid stimulating hormone and thyroid autoantibodies	5 years
Other	Level of free cortisol rhythm	To assess the function of adrenal gland by measuring the level of free cortisol rhythm	5 years
Other	Occurrence of rheumatic diseases	Rheumatic antibody	5 years
Primary	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	Occurrence of subclinical ASCVD(carotid plaque)	Carotid plaque(IMT>1.5mm)	5 years
Secondary	Occurrence of subclinical ASCVD(carotid intima-media thickness)	Carotid intima-media thickness(CIMT)=0.9mm	5 years
Secondary	Occurrence of subclinical ASCVD(pulse wave velocity)	Pulse wave velocity(PWV)>6.8m/s	5 years
Secondary	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)	5 years