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Intima Media Thickness Regression in Dyslipidemic Teenagers

This study has been completed.
Information provided by (Responsible Party):
Laurent Legault, Université de Montréal Identifier:
First received: January 8, 2013
Last updated: January 11, 2013
Last verified: January 2013
Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.

Condition Intervention Phase
Drug: Atorvastatin
Drug: sugar pill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque

Resource links provided by NLM:

Further study details as provided by Laurent Legault, Université de Montréal:

Primary Outcome Measures:
  • carotid intima media thickness [ Time Frame: 12 months ]
    Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin)

Secondary Outcome Measures:
  • weight [ Time Frame: 12 months ]
    weight, height and BMI recorded before and after intervention

Other Outcome Measures:
  • Lipid profile [ Time Frame: 6 months ]
    Complete lipid profile were recorded at baseline , 6 months and 12 months after intervention.

  • lipid profile [ Time Frame: 12 months ]
    Lipid profile measured at end of study

  • BMI [ Time Frame: 12 months ]
    BMI neasured at baseline and at end of study

  • liver functions [ Time Frame: 3 months ]
    ALT/AST done at 3, 6, 9 and 12 months

  • liver functions [ Time Frame: 6 months ]
    ALT/AST done at 3, 6, 9, and 12 months

  • liver functions [ Time Frame: 9 months ]
    ALT/AST done at 3, 6, 9, and 12 months

  • liver functions [ Time Frame: 12 months ]
    ALT/AST done at 3, 6, 9, and 12 months

  • creatinine kinase [ Time Frame: 3 months ]
    CK done at 3 , 6, 9 and 12 months

  • creatinine kinase [ Time Frame: 6 months ]
    CK done at 3 , 6, 9 and 12 months

  • creatinine kinase [ Time Frame: 9 months ]
    CK done at 3 , 6, 9 and 12 months

  • creatinine kinase [ Time Frame: 12 months ]
    CK done at 3 , 6, 9 and 12 months

Enrollment: 16
Study Start Date: January 2004
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Statin
Atorvastatin 10 mg every day for one year
Drug: Atorvastatin
10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year
Other Names:
  • Statin
  • Lipitor
Placebo Comparator: Sugar pill
Same size, taste and size placebo tablet (manufactured by sponsor) given every day for one year.
Drug: sugar pill
placebo controlled arm receives similarly looking placebo.
Other Name: placebo

Detailed Description:
Obese teenagers with abnormal lipid profiles were randomized to either low dose statin or placebo and had their carotid intima media thickness compared before and after intervention.

Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Obesity
  • Abnormal Triglyceride levels (>1.7mmol/L).
  • Abnormal HDL-C levels (1.0mmol/L)

Exclusion Criteria:

  • Abnormal thyroid unfction (not treated)
  • Diabetes
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Please refer to this study by its identifier: NCT01768481

Canada, Quebec
Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Université de Montréal
Principal Investigator: Laurent Legault, MD Hopital Maisonneuve-Rosemont, UMontreal
  More Information

Responsible Party: Laurent Legault, associate professor, Université de Montréal Identifier: NCT01768481     History of Changes
Other Study ID Numbers: HMR
Study First Received: January 8, 2013
Last Updated: January 11, 2013

Keywords provided by Laurent Legault, Université de Montréal:
Intima media thickness

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017