Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT) - Full Text View

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00130481

Purpose

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
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus	Drug: Atorvastatin 20 mg daily for 3 months

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

Further study details as provided by University of Florida:

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)

Estimated Enrollment:	100
Study Start Date:	April 2005
Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	10 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130481

Locations

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Michael J Haller, MD

University of Florida

More Information

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.

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

Keywords provided by University of Florida:

Diabetes
Children
Adolescents
Arterial Compliance
Physiology Cardiovascular Endothelium

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009