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Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130481
First Posted: August 15, 2005
Last Update Posted: March 7, 2012
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.
Information provided by (Responsible Party):
University of Florida
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

Resource links provided by NLM:


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
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

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
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
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 ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00130481     History of Changes
Other Study ID Numbers: 576-2004
GCRC M-01 RR 000082
Pfizer 2004-0926
DARE 187
First Submitted: August 12, 2005
First Posted: August 15, 2005
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by University of Florida:
Diabetes
Children
Adolescents
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors