Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Children, Adolescents, Arterial Compliance, Physiology Cardiovascular Endothelium
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.
Interventions
DRUGAtorvastatin 20 mg daily for 3 months
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Augmentation Index (arterial stiffness) | — |
| ENDO-PAT (Peripheral Arterial Tone) score (endothelial function) | — |
| Low density lipoprotein | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure | — |
| Urine microalbumin | — |
| Glycated hemoglobin (HbA1c) | — |
| Pubertal stage | — |
| Body mass index (BMI) | — |
Countries
United States
Outcome results
None listed