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 18, 2015
Last verified: May 2015
Results First Received: December 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
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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  
Number of Participants  
[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:   If the Use of Statins in Children With Type 1 DM is Safe, Improves Measures of LDL-C.   [ Time Frame: Randomization and 6 months ]

2.  Primary:   If the Use of Statins in Children With Type 1 DM Decreases the Concentration of Inflammatory Markers.   [ 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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   No


  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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nelly Mauras, MD
Organization: Nemours Children's Clinic
phone: 904-697-3674
e-mail: nmauras@nemours.org


Publications of Results:

Responsible Party: Nelly Mauras, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01236365     History of Changes
Other Study ID Numbers: IRB# 185500
Study First Received: November 2, 2010
Results First Received: December 29, 2014
Last Updated: May 18, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration