Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.
研究概览
简要总结
The purpose of the study is to establish the safety of ezetimibe/simvastatin and simvastatin in adolescents with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterol.The study hypothesizes that simvastatin and ezetimibe/simvastatin will be safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.
详细描述
Cardiovascular disease is the leading cause of death in people with type 1 diabetes mellitus (T1DM) and since atherosclerosis begins in childhood, data to inform clinicians as to appropriate dyslipidemia treatment in this high-risk population are of great public health importance. In this trial of lipid-lowering medications (Zocor [simvastatin], a statin, compared to Vytorin [ezetimibe/simvastatin], a combination of a statin and Zetia, a medication that blocks cholesterol absorption) will be performed in patients ages 12-18 years with LDL ≥ 130 mg/dl, consistent with current ADA guidelines. The study hypothesizes that Zocor and Vytorin will be safe in adolescents with T1DM and will lower LDL-cholesterol at 6 months compared to baseline. In a two-arm design, Vytorin will lower LDL-c more than monotherapy with Zocor.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-18 years of age with Type 1 Diabetes and seen at the Barbara Davis Center for Childhood Diabetes
- •Positive diabetes auto-antibodies or provider diagnosed Type 1 Diabetes
- •LDL > 130 mg/dl.
排除标准
- •Familial hypercholesterolemia, Triglycerides (TG) > 400mg/dl
- •Type 1 Diabetes of less than three-month duration
- •HbA1c>9.5%
- •Abnormal thyroid function
- •Abnormal Creatine Kinase (CK) values (defined as > 10 times the upper limit of normal)
- •Abnormal liver function tests (ALT/AST) (defined as >3 times the upper limit of normal)
- •Pregnancy, and patients on oral contraceptives
- •All resources are in English. Spanish speakers will not be available for the follow-up calls.
研究组 & 干预措施
Simvastatin
Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin [simvastatin] + Zetia [ezetimibe].
干预措施: Simvastatin (Drug)
Ezetimibe/Simvastatin
Vytorin(simvastatin [Zocor} + ezetimibe [Zetia])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin [simvastatin]).
干预措施: Ezetimibe/Simvastatin (Drug)
结局指标
主要结局
Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.
时间窗: Baseline to 6 months
Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.
次要结局
未报告次要终点