Statins in Children With Type 1 Diabetes and Hypercholesterolemia

Summary

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.

Conditions

• Diabetes Mellitus, Insulin-Dependent
• Hypercholesterolemia

Interventions

DRUG

Atorvastatin

10 or 20 mg daily

DRUG

Atorvastatin Placebo

10 or 20 mg daily

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• Medtronic

  collaborator INDUSTRY

• Quest Diagnostics-Nichols Insitute

  collaborator INDUSTRY

• Nemours Children's Clinic

  lead OTHER

Principal Investigators

• Nelly Mauras, MD · Nemours Children's Clinic 807 Children's Way Jacksonville, Florida 32207

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2013-10-31

Completion

2014-11-30

Countries

• United States

Study Locations