Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if Atorvastatin can improve blood vessel stiffness and blood vessel function in children 10-18 years old with Type 1 and Type 2 diabetes. Subjects will receive atorvastatin 20mg or placebo daily for 3 months and will then switch therapies for the next 3 months.

Hypothesis: Atorvastatin will improve blood vessel function by decreasing arterial stiffness and improving blood flow.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) for more than 1 year

• Age 10-18 years.

Exclusion Criteria:

• Cardiovascular disease (CVD)

• Liver disease

• Pregnancy

• Use of cholesterol or triglyceride lowering drugs

• Perceived inability to comply with the study protocol

• Endocrinopathy other than diabetes