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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014