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NCT Number: NCT05294653

Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes

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.

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Autoimmune Diseases Cardiovascular Diseases Childhood Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Juvenile Diabetes Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, 200025, China

Location contact

Weiqiong Gu, PhD

CONTACT

[email protected]

64370045 ext. 672701

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Occurrence of Atherosclerotic Cardiovascular Disease(ASCVD) high risk rating

    Time frame: 5 years

    Risk value calculated by QRISK3 model >10% (The QRISK®3-2018 risk calculator https://qrisk.org/three)

Secondary outcomes

  1. Occurrence of subclinical ASCVD(carotid plaque)

    Time frame: 5 years

    Carotid plaque(IMT>1.5mm)

  2. Occurrence of subclinical ASCVD(carotid intima-media thickness)

    Time frame: 5 years

    Carotid intima-media thickness(CIMT)≥0.9mm

  3. Occurrence of subclinical ASCVD(pulse wave velocity)

    Time frame: 5 years

    Pulse wave velocity(PWV)>6.8m/s

  4. Occurrence of subclinical ASCVD(coronary artery calcium)

    Time frame: 5 years

    Coronary artery calcium(CAC) score>0 (CAC:assessed only when subclinical ASCVD events confirmed by IMT, CIMT, PWV)

Other outcomes

  1. Glycemic control(glycated hemoglobin)

    Time frame: 5 years

    To study glycemic control by comparing glycated hemoglobin(HbA1c)

  2. Glycemic control(free blood glucose)

    Time frame: 5 years

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

  3. Glycemic control(postprandial blood glucose)

    Time frame: 5 years

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

  4. Glycemic control(severe hypoglycemia events)

    Time frame: 5 years

    Severe hypoglycemia events in the past six months

  5. Islet function(fasting C peptide)

    Time frame: 5 years

    To study the residual β-cell function by using fasting C peptide(FCP)

  6. Islet function(2-hour post-meal stimulated C peptide)

    Time frame: 5 years

    To study the residual β-cell function by using 2-hour post-meal stimulated C peptide (PCP) with MMTT

  7. Islet function(pancreatic enhanced MR)

    Time frame: 5 years

    Volume of the pancreas(ml) calculated by pancreatic enhanced MR

  8. Daily insulin dosage

    Time frame: 5 years

    To study the insulin requirement by using daily insulin dosage per body weight (DID IU/kg.d)

  9. Frequency of daily moderate to high-intensity aerobic exercise

    Time frame: 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%)]

  10. Occurrence of diabetic nephropathy

    Time frame: 5 years

    Urine microalbumin (MA)/creatinine (Cr) ratio

  11. Concentration of cardiac troponin T

    Time frame: 5 years

    To assess the myocardial function by cardiac troponin T(cTnI)

  12. Level of high-sensitivity C-reactive protein

    Time frame: 5 years

    To assess the extent of inflammation by high-sensitivity C-reactive protein (hs-CRP)

  13. Occurrence of diabetic retinopathy

    Time frame: 5 years

    Retinal photography

  14. Level of cardiac function

    Time frame: 5 years

    Echocardiography

  15. Occurrence of diabetic neuropathy

    Time frame: 5 years

    Electrophysiological testing

  16. Level of thyroid hormones

    Time frame: 5 years

    To assess the occurrence of thyroiditis by thyroid function including triiodothyronine, tetraiodothyronine, thyroid stimulating hormone and thyroid autoantibodies

  17. Level of free cortisol rhythm

    Time frame: 5 years

    To assess the function of adrenal gland by measuring the level of free cortisol rhythm

  18. Occurrence of rheumatic diseases

    Time frame: 5 years

    Rheumatic antibody

Study contacts

Contact information is provided by the study sponsor or research team.

Weiqiong Gu, PhD

CONTACT

[email protected]

64370045 ext. 671701

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2022
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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