Statins in Children With Type 1 Diabetes and Hypercholesterolemia
2019年6月4日 更新者:Nelly Mauras、Nemours Children's Clinic
Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function
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.
研究概览
研究类型
介入性
注册 (实际的)
42
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Delaware
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Wilmington、Delaware、美国
- Alfred I duPont Hospital
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Florida
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Jacksonville、Florida、美国、32207
- Nemours Children's Clinic
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Orlando、Florida、美国
- Nemours Children's Clinic
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Pensacola、Florida、美国、32504
- Nemours Children's Clinic
-
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Nemours Children's Clinic-Jefferson
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 至 20年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:Project 1
- 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
Exclusion Criteria:Projects 1,2 and 3
- Severe dyslipidemia (LDL-C >160, TG > 400 mg/dl)
- Smoking
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂
|
10 or 20 mg daily
|
实验性的:阿托伐他汀
|
10 or 20 mg daily
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
LDL-C Levels Assessed at Randomization and 6 Months
大体时间: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.
|
Randomization and 6 months
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Hs-CRP Levels Assessed at Randomization and 6 Months
大体时间:Randomization and 6 months
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To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers.
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Randomization and 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
MAGE
大体时间:Randomization and 6 months
|
Mean amplitude of glycemic excursion (MAGE) with continuous glucose monitoring (CGM - IPro®, Medtronic Minimed) worn blindly for 6d to assess glucose variability
|
Randomization and 6 months
|
RAGE
大体时间:Randomization and 6 months
|
Receptor for Advanced Glycation End Products
|
Randomization and 6 months
|
Descending Aortic Strain
大体时间:Randomization
|
Subclinical atherosclerosis and arterial stiffness of abdominal aortic MRI
|
Randomization
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Nelly Mauras, MD、Nemours Children's Clinic 807 Children's Way Jacksonville, Florida 32207
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Canas JA, Ross JL, Taboada MV, Sikes KM, Damaso LC, Hossain J, Caulfield MP, Gidding SS, Mauras N. A randomized, double blind, placebo-controlled pilot trial of the safety and efficacy of atorvastatin in children with elevated low-density lipoprotein cholesterol (LDL-C) and type 1 diabetes. Pediatr Diabetes. 2015 Mar;16(2):79-89. doi: 10.1111/pedi.12245. Epub 2014 Nov 22.
- McCulloch MA, Mauras N, Canas JA, Hossain J, Sikes KM, Damaso LC, Redheuil A, Ross JL, Gidding SS. Magnetic resonance imaging measures of decreased aortic strain and distensibility are proportionate to insulin resistance in adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2015 Mar;16(2):90-7. doi: 10.1111/pedi.12241. Epub 2014 Dec 18.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年10月1日
初级完成 (实际的)
2013年10月1日
研究完成 (实际的)
2014年11月1日
研究注册日期
首次提交
2010年11月2日
首先提交符合 QC 标准的
2010年11月5日
首次发布 (估计)
2010年11月8日
研究记录更新
最后更新发布 (实际的)
2019年6月25日
上次提交的符合 QC 标准的更新
2019年6月4日
最后验证
2019年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.