- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00130481
Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Augmentation Index (arterial stiffness)
|
ENDO-PAT (Peripheral Arterial Tone) score (endothelial function)
|
Low density lipoprotein
|
Secondary Outcome Measures
Outcome Measure |
---|
Blood pressure
|
Body mass index (BMI)
|
Urine microalbumin
|
Pubertal stage
|
Glycated hemoglobin (HbA1c)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Haller MJ, Samyn M, Nichols WW, Brusko T, Wasserfall C, Schwartz RF, Atkinson M, Shuster JJ, Pierce GL, Silverstein JH. Radial artery tonometry demonstrates arterial stiffness in children with type 1 diabetes. Diabetes Care. 2004 Dec;27(12):2911-7. doi: 10.2337/diacare.27.12.2911.
- Haller MJ, Stein JM, Shuster JJ, Theriaque D, Samyn MM, Pepine C, Silverstein JH. Pediatric Atorvastatin in Diabetes Trial (PADIT): a pilot study to determine the effect of atorvastatin on arterial stiffness and endothelial function in children with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2009 Jan;22(1):65-8. doi: 10.1515/jpem.2009.22.1.65.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Diabetes Mellitus, Type 1
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- 576-2004
- GCRC M-01 RR 000082
- Pfizer 2004-0926
- DARE 187
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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