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Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

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ClinicalTrials.gov Identifier: NCT00130481
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Drug: Atorvastatin 20 mg daily for 3 months

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Primary Completion Date : April 2007
Study Completion Date : April 2007


Arms and Interventions


Outcome Measures

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)

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: August 15, 2005    Key Record Dates
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