DRKS00007662招募中不适用
Diagnostics of Early Atherosclerosis Risk in Kids - DEAR-Kids
Pädiatrische Endokrinologie und DiabetologieKlinik für Allgemeine PädiatrieZentrum für Kinder- und Jugendmedizin0 个研究点目标入组 900 人开始时间: 2015年3月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 4 Years 至 18 Years（—）
- 性别
- All
入选标准
- •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
- •b. Duration of disease at least 1 year
- •3. Diabetes mellitus type 2
- •a. Diagnosis of diabetes by criteria of the
- •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
- •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
排除标准
- •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
- •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
- •8. Arterial Hypertension
- •9. Renal insufficiency
- •10. Ullrich-Turner Syndrom
- •11. Methylmalonaziduria und Propionaziduria or other metabolic diseases
- •a. Incompliance related to therapy with carnitine
- •b. Acute metabolic disbalance
- •12. Prader Willi syndrome
- •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
研究者
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