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临床试验/NCT01236365
NCT01236365已完成3 期

Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function

Nemours Children's Clinic3 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
42
试验地点
3
主要终点
LDL-C Levels Assessed at Randomization and 6 Months

研究概览

简要总结

Children with type1 diabetes (T1DM) have increased risk for cardiovascular disease (CVD) due to chronic increase in the blood sugars and inflammation. If there is also increased in cholesterol, it creates a highly abnormal environment not fully corrected by improved control of the blood sugars. CVD remains the principal risk of mortality in T1DM, and its prevention and treatment, compelling in children. This grant proposal encompasses 3 separate, yet interrelated projects addressing different aspects of CVD risk in children with T1DM. Project #1: a randomized controlled trial on the safety and efficacy of a class of drugs called "statins", which lower bad cholesterol in the body, in children with diabetes and elevated bad cholesterol. We will measure changes in concentration of blood inflammatory markers and for the 1st time, correlate levels of these markers with changes in blood sugar as measured by continuous glucose sensors, instruments that measure the blood sugar continuously through a small needle under the skin. Project #2: is a laboratory study to investigate the genetics and concentration of key molecules that participate in the inflammatory cascade and atheromatous plaque formation that causes CVD. Expression levels in children with T1DM will be compared with those in healthy controls for the 1st time. Project #3: examines the use of abdominal aortic MRI to measure damage to the arteries in children with T1DM and healthy age-matched controls. The results of these studies will likely provide important new data on the use of statins in children with diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • T1DM diagnosed clinically for > 1 year
  • any HbA1C
  • on stable insulin therapy
  • Ages: 10 - 20 years
  • both genders
  • BMI < 85th percentile
  • Fasting LDL-C>100mg/dl
  • Normal thyroid function
  • Inclusion Criteria:Projects 2 and 3
  • T1DM diagnosed clinically for > 3 year
  • HbA1C > 8%
  • on stable insulin therapy
  • Ages: 12- 20 years
  • both genders
  • BMI < 85th percentile
  • Fasting LDL-C>100mg/dl
  • Normal thyroid function

排除标准

  • Projects 1,2 and 3
  • Severe dyslipidemia (LDL-C >160, TG > 400 mg/dl)
  • Pregnancy
  • Current use of anti-inflammatory or immunomodulatory drugs, lipid lowering, antidiabetic drugs
  • Patients with hypertension and/or microalbuminuria will be allowed using balanced randomization and standardized treatment

研究组 & 干预措施

Atorvastatin

Experimental

干预措施: Atorvastatin (Drug)

Placebo

Placebo Comparator

干预措施: Atorvastatin Placebo (Drug)

结局指标

主要结局

LDL-C Levels Assessed at Randomization and 6 Months

时间窗: Randomization and 6 months

To assess if the use of statins in children with type 1 DM is safe, improves measures of LDL-C. Subjects will have a physical exam, laboratories, nutritional counseling and moderate aerobic exercise recommended. Diabetes management will be intensified. At 3 months fasting lipoprotein fractions (ion mobility)re-drawn and if LDL-C \>100mg/dl patients will be randomized to treatment with statins or placebo for 6 months, randomization stratified by BP and microalbuminuria, duration of diabetes and HgA1C. At 1 month safety labs will be repeated and blood withdrawn again at 3 and 6 months from baseline.

Hs-CRP Levels Assessed at Randomization and 6 Months

时间窗: Randomization and 6 months

To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers.

次要结局

  • RAGE(Randomization and 6 months)
  • MAGE(Randomization and 6 months)
  • Descending Aortic Strain(Randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nelly Mauras

Chief, Division of Endocrinology, Diabetes & Metabolism

Nemours Children's Clinic

研究点 (3)

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