Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130481
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : March 7, 2012
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Drug: Atorvastatin 20 mg daily for 3 months Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)
Study Start Date : April 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Primary Outcome Measures :
  1. Augmentation Index (arterial stiffness)
  2. ENDO-PAT (Peripheral Arterial Tone) score (endothelial function)
  3. Low density lipoprotein

Secondary Outcome Measures :
  1. Urine microalbumin
  2. Pubertal stage
  3. Body mass index (BMI)
  4. Blood pressure
  5. Glycated hemoglobin (HbA1c)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00130481

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Principal Investigator: Michael J Haller, MD University of Florida

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Florida Identifier: NCT00130481     History of Changes
Other Study ID Numbers: 576-2004
GCRC M-01 RR 000082
Pfizer 2004-0926
DARE 187
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by University of Florida:
Arterial Compliance
Physiology Cardiovascular Endothelium

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors