Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

University of Florida100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

100

Conditions

Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Interventions

Atorvastatin 20 mg daily for 3 monthsDRUG

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Augmentation Index (arterial stiffness)

ENDO-PAT (Peripheral Arterial Tone) score (endothelial function)

Low density lipoprotein

Secondary Outcomes

Urine microalbumin

Pubertal stage

Body mass index (BMI)

Blood pressure

Glycated hemoglobin (HbA1c)

Data from ClinicalTrials.gov

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