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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00130481 |
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.
Condition | Intervention |
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Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus |
Drug: Atorvastatin 20 mg daily for 3 months |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT) |
Estimated Enrollment: | 100 |
Study Start Date: | April 2005 |
Study Completion Date: | April 2007 |
Ages Eligible for Study: | 10 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610 |
Principal Investigator: | Michael J Haller, MD | University of Florida |
Study ID Numbers: | 576-2004, GCRC M-01 RR 000082, Pfizer 2004-0926, DARE 187 |
Study First Received: | August 12, 2005 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00130481 |
Health Authority: | United States: Institutional Review Board |
Diabetes Children Adolescents Arterial Compliance Physiology Cardiovascular Endothelium |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Atorvastatin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |