Abstract
Herein, we describe recruitment efforts for a trial of lipid-lowering medications in adolescents with type 1 diabetes, age 12–21 years. Based on our experience, future studies will require multiple centers to enroll a sufficient number of participants for adequate data to direct dyslipidemia medication treatment guidelines for adolescents with type 1 diabetes.
Highlights
We describe recruitment efforts for a trial of lipid-lowering medications in adolescents with type 1 diabetes, age 12–21 years
We proposed a trial of lipid-lowering medications in our patients ages 12–21 years with LDL ≥ 130 mg/dl, consistent with current American Diabetes Association (ADA) guidelines
We hypothesized that simvastatin and Vytorin would be safe in adolescents with type 1 diabetes (T1D) and that in a two-arm design, Vytorin would lower low-density lipoprotein cholesterol (LDL-c) more than monotherapy with simvastatin at 6 months compared to baseline
Summary
We describe recruitment efforts for a trial of lipid-lowering medications in adolescents with type 1 diabetes, age 12–21 years. We proposed a trial of lipid-lowering medications (simvastatin, a statin, compared to Vytorin, a combination of simvastatin and ezetimibe, a medication that blocks cholesterol absorption) in our patients ages 12–21 years with LDL ≥ 130 mg/dl, consistent with current American Diabetes Association (ADA) guidelines. We describe observations from a trial of lipid-lowering medications in T1D, age 12–21 years.
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