Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)
4 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 12, 2005
CompletedFirst Posted
Study publicly available on registry
August 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMarch 7, 2012
March 1, 2012
2 years
August 12, 2005
March 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Augmentation Index (arterial stiffness)
ENDO-PAT (Peripheral Arterial Tone) score (endothelial function)
Low density lipoprotein
Secondary Outcomes (5)
Urine microalbumin
Pubertal stage
Body mass index (BMI)
Blood pressure
Glycated hemoglobin (HbA1c)
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) for more than 1 year
- Age 10-18 years.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
Related Publications (2)
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.
PMID: 15562206BACKGROUNDHaller 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.
PMID: 19344076DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Haller, MD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2005
First Posted
August 15, 2005
Study Start
April 1, 2005
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
March 7, 2012
Record last verified: 2012-03