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Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

Primary Purpose

Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin 20 mg daily for 3 months
Sponsored by
University of Florida
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes Mellitus focused on measuring Diabetes, Children, Adolescents, Arterial Compliance, Physiology Cardiovascular Endothelium

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida

Outcomes

Primary Outcome Measures

Augmentation Index (arterial stiffness)
ENDO-PAT (Peripheral Arterial Tone) score (endothelial function)
Low density lipoprotein

Secondary Outcome Measures

Urine microalbumin
Pubertal stage
Body mass index (BMI)
Blood pressure
Glycated hemoglobin (HbA1c)

Full Information

First Posted
August 12, 2005
Last Updated
March 6, 2012
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00130481
Brief Title
Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)
Official Title
Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Keywords
Diabetes, Children, Adolescents, Arterial Compliance, Physiology Cardiovascular Endothelium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20 mg daily for 3 months
Primary Outcome Measure Information:
Title
Augmentation Index (arterial stiffness)
Title
ENDO-PAT (Peripheral Arterial Tone) score (endothelial function)
Title
Low density lipoprotein
Secondary Outcome Measure Information:
Title
Urine microalbumin
Title
Pubertal stage
Title
Body mass index (BMI)
Title
Blood pressure
Title
Glycated hemoglobin (HbA1c)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Haller, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15562206
Citation
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.
Results Reference
background
PubMed Identifier
19344076
Citation
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.
Results Reference
derived

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Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

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