Diagnostics of Early Atherosclerosis Risk in Kids

Recruiting

• Conditions: E10.90; E66.99; E11.90; E13.90; E78.9; I10.90; N18.9; Q96.9; Q87.1; P05.9

• Registration Number: DRKS00007662
• Lead Sponsor: Pädiatrische Endokrinologie und DiabetologieKlinik für Allgemeine PädiatrieZentrum für Kinder- und Jugendmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Einschlusskriterien

1. General:
a. Signed informed consent
b. Age = 7 - <18 years at signature of informed consent

2. Diabetes mellitus type 1:
a. Diagnosis of diabetes by criteria of the
ADA/DDG.
b. Duration of disease at least 1 year

3. Diabetes mellitus type 2
a. Diagnosis of diabetes by criteria of the
ADA/DDG.

4. Cystic fibrosis related Diabetes mellitus
a. Diagnosis of Cystic fibrosis related Diabetes mellitus (by pathologic oral glucose tolerance test or pathologic fasting glucose)

5. Obesity:
a. Body Mass Index (BMI) > 97. age appropriate percentile (Deutsche
synthetische Normkurve, patients of different ethnicity respective percentiles).

6. Healthy controls
a. Absence of diseases with influence on atherosclerosis risk.

7. Hypercholesterolemia
a. total cholesterol > 250 mg/dl or LDL cholesterol >160 mg/dl or
LDL/HDL ratiot >3
b. Treatment with medication against hypercholesterolemia and cholesterol levels that don't fit 7a.

8. Arterial Hypertension
a. Arterial Hypertension according to the guidelines of Deutsche Gesellschaft
für pädiatrische Kardiologie

9. Renal insufficiency
a. Chronic renal insufficiency, at least grade III (Crea Clearance <60ml/min, calculated by new Schwartz-formula; 0,413 x lenght in
cm / blood creatinine in mg/dl

10. Ullrich-Turner syndrome
a. Diagnosis of Ullrich-Turner-syndrome or Ullrich-Turner syndrome mosaic by chromosomal analysis

11. Methylmalonaziduria und Propionaziduria or other metabolic diseases
a. Patients with methylmalonaziduria or propionaziduria or other metabolic diseases
diagnosed by generally accepted criteria
(metabolic laboratory tests, genetics)
b. Therapy with carnitine

12. Prader Willi syndrome
a. Prader Willi syndrome (genetically diagnosed)

13. Growth hormone deficiency
a. Growth hormone deficiency (diagnosed with two pathologic stimulation tests)
b. therapy with recombinant Growth hormone or completed therapy with recombinant Growth hormone

14. Birth small for gestational age
a. Length and/or weight SDS < -2 at birth
b. therapy with recombinant growth hormone
or
c. length SDS < -2,5 und growth velocity SDS < 0 and difference of at least one SDS to genetic target length at beginning of growth hormone replacement

For another arm of the study, following inclusion criteria are applied:

a. Prepubertal patients aged 4-10 years
b. Presence of Growth hormone deficiency, Small for gestational age birth with indication for growth hormone treatment, Ullrich Turner Syndrome, Prader Willi Syndrome OR absence of atherosclerosis risk modifying diseases
c. Before start of growth hormone therapy OR after at least 1 year of growth hormone therapy
d. Signed informed consent

Exclusion Criteria

Ausschlusskriterien

1. General:
a. Acute inflammatory or infectious disease at the time of examination/venous puncture
b. Temperaturer >38,5°C at the time of examination/venous puncture
c. Diseases with vascular malformation
d. Thrombophilia

2. Diabetes mellitus type 1
a. other forms of diabetes mellitus (e.g. Cystic fibrosis related Diabetes, monogenic forms of diabetes).

3. Diabetes mellitus type 2
none

4. Cystic fibrosis related Diabetes mellitus
a. Acute pulmonary exacerbation with fever and/or intravenous antibiotic therapy
b. pulmonary transplantation
c. Listed for pulmonary transplantation

5. Obesity
a. Syndromic forms of obesity (e.g. Prader Willi syndrome), Cushings syndrome, hypothyreoidism without therapy
b. Pathologic oral glucose tolerance test (in this case inclusion in group 3).

6. Healthy controls
a. preterm birth < 35. + 0. weeks of gestation
b. Inclusion criteria for another group met

7. Hypercholesterolemia
a. none

8. Arterial Hypertension
a. none

9. Renal insufficiency
a. none

10. Ullrich-Turner Syndrom
a. none

11. Methylmalonaziduria und Propionaziduria or other metabolic diseases
a. Incompliance related to therapy with carnitine
b. Acute metabolic disbalance

12. Prader Willi syndrome
a. none

13. Growth hormone deficiency
a. Secondary Growth hormone deficiency (e.g. post operative, after radiation)

14. Birth Small for gestational Age
a. Known or obvious syndromic disease

For another arm of the study, following exclusion criteria are applied:

a. Patients with defined comorbidities with an influence on cardiovascular risk as e.g. Trisomy 21 or familial hypercholesterolemia.
b. Acute inflammatory or infectious disease at study inclusion
c. Fever (defined as temperature >38,5°C)
d. Vascular malformation or diseases, that usually comprise vascular malformation
e. Thrombophilia
f. Preterm birth before gestational age of 35 + 0 weeks

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of diagnostic techniques for early diagnosis of atherosclerotic changes in childhood and compilation of normative values for healthy children.

Secondary Outcome Measures

Name	Time	Method
*Comparison of different diagnostic techniques and correlation of results on the early diagnosis of atherosclerotic changes. <br>*Analysis of differences in early atherosclerotic changes in patient groups compared to control group.<br>*Correlation of results to clnical characteristics like disease duration, quality of therapy (e.g. HbA1c), duration of therapy etc.<br>*Correlation of results to known risk factors for atherosclerosis like smoking, weight, blood pressure, sedentary lifestyle etc. <br>*Compilation of risk profiles / mutual risk constellations with latent class models.<br>