Conditions: Type 1 Diabetes Mellitus Dyslipidemia
Keywords: Type 1 Diabetes Mellitus dyslipidemia adolescents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin \[simvastatin\] + Zetia \[ezetimibe\]. arm 2: Vytorin(simvastatin \[Zocor} + ezetimibe \[Zetia\])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin \[simvastatin\]).

Interventions: intervention 1: Simvastatin intervention 2: Ezetimibe/Simvastatin
Intervention descriptions: intervention 1: simvastatin 20 mg daily intervention 2: Ezetimibe (10mg)/Simvastatin (20mg)

Protocol document: