Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

University of Florida

Status: Completed

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Treatments: Drug: Atorvastatin 20 mg daily for 3 months

Study type: Interventional

Funder types: Other

Identifiers

NCT00130481

576-2004

Pfizer 2004-0926

GCRC M-01 RR 000082

DARE 187

Details and patient eligibility

About

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.

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind