Collecting reference values for arterial stiffness and insulin resistance in healthy adolescents

Completed

Conditions: Arteriosclerosis
diabetes
10018424
10003216

Registration Number: NL-OMON37777

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 147

Inclusion Criteria

- Subjects age * 10 and < 20 years.
- BMI-SDS > -1.1 and <1.1 (normal weight).
- Caucasian descent.
- Signed informed consent from subjects and parents/caregivers (if applicable).

Exclusion Criteria

- Absence of a venous cannula for scheduled surgery.
- Presence of T1DM or T2DM.
- Hypertension defined as blood pressure >p95 for age, sex and height.
- Use of corticosteroids, antihyperglycaemic drugs and/or antihypertensive drugs. ;To make sure that the measurements will not be influenced by renal insufficiency the glomerular filtration rate (GFR) will be measured. Also to make sure that the subjects will not have infections that influence the PWV, CRP will be measured. Subjects will be excluded if:
- GFR < 80 ml/min.1,73m² (GFR=40*length(cm)/serumcreatinin (*mol/l)
or
- C-reactive protein concentration >10 mg/l

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters of this study are:<br /><br>The reference values of the arterial stiffness, measured as PWV (ms-1) and the<br /><br>AIx (%) and insulin resistance, calculated as HOMA-IR of different Tanner<br /><br>stages in adolescents. These values will be expressed as mean, standard<br /><br>deviation and percentiles.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Cardiovascular parameters: blood pressure, heart rate, lipid profile and<br /><br>renal function.<br /><br>- Demografic and anthropometric characteristics: sex, anthropometrics,<br /><br>bio-impedance, Tanner stage (I:1, II:2+3, III: 4+5).<br /><br>- Family history on diabetes mellitus, hypertension, cardiovascular disease,<br /><br>dislipidaemia and obesity. The family history will be reported as positive or<br /><br>negative and if positive, will be defined as first degree relatives (parents,<br /><br>siblings) and/or second degree relatives (grandparents).<br /><br>- Lifestyle: smoking, use of medicines, weekly exercise in hours, weekly amount<br /><br>of computer and television use in hours.</p><br>