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Statins in Children With Type 1 Diabetes and Hypercholesterolemia

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Medtronic
Quest Diagnostics
Information provided by (Responsible Party):
Nelly Mauras, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01236365
First received: November 2, 2010
Last updated: May 21, 2015
Last verified: May 2015
Results First Received: December 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Insulin-Dependent
Hypercholesterolemia
Interventions: Drug: Atorvastatin
Drug: Atorvastatin Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Atorvastatin Atorvastatin: 10 or 20 mg daily
Placebo Placebo: 10 or 20 mg daily

Participant Flow:   Overall Study
    Atorvastatin   Placebo
STARTED   21   21 
COMPLETED   19   19 
NOT COMPLETED   2   2 
Lost to Follow-up                0                2 
Moved Out of State                1                0 
Dropped at Randomization due to high LFT                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Atorvastatin Atorvastatin: 10 or 20 mg daily
Placebo Atorvastatin Placebo: 10 or 20 mg daily
Total Total of all reporting groups

Baseline Measures
   Atorvastatin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   21   42 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.9  (2.2)   15.4  (2.7)   15.1  (2.4) 
Gender 
[Units: Participants]
     
Female   11   9   20 
Male   10   12   22 
Race/Ethnicity, Customized 
[Units: Participants]
     
non-Hispanic white   17   14   31 
Other   4   7   11 
Region of Enrollment 
[Units: Participants]
     
United States   21   21   42 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   LDL-C Levels Assessed at Randomization and 6 Months   [ Time Frame: Randomization and 6 months ]

2.  Primary:   Hs-CRP Levels Assessed at Randomization and 6 Months   [ Time Frame: Randomization and 6 months ]

3.  Secondary:   Relationship Between Glycemic Variability- Measured by the Mean Amplitude of Glycemic Excursion With Continuous Glucose Monitoring.   [ Time Frame: Randomization and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Gene Expression and Concentration of Key Molecules That Participate in the Inflammatory Process and Arterial Plaque Formation.   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Subclinical Atherosclerosis and Vascular Stiffness With the Use of Abdominal Aortic MRI.   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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