Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

• Registration Number: NCT00130481
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-15
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Augmentation Index (arterial stiffness)
ENDO-PAT (Peripheral Arterial Tone) score (endothelial function)
Low density lipoprotein

Secondary Outcome Measures

Name	Time	Method
Urine microalbumin
Pubertal stage
Body mass index (BMI)
Blood pressure
Glycated hemoglobin (HbA1c)

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States