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Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00130481
First received: August 12, 2005
Last updated: March 6, 2012
Last verified: March 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

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
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, see Learn About Clinical Studies.

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:
Additional 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
Study First Received: August 12, 2005
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014