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Intima Media Thickness Regression in Dyslipidemic Teenagers

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ClinicalTrials.gov Identifier: NCT01768481
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : January 15, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Laurent Legault, Université de Montréal

Brief Summary:
Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.

Condition or disease Intervention/treatment Phase
Obesity Dyslipidemia Drug: Atorvastatin Drug: sugar pill Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque
Study Start Date : January 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. weight [ Time Frame: 12 months ]
    weight, height and BMI recorded before and after intervention


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

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

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

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

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

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

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

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

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

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

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



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

Inclusion Criteria:

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

Exclusion Criteria:

  • Abnormal thyroid unfction (not treated)
  • Diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768481


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

Responsible Party: Laurent Legault, associate professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01768481     History of Changes
Other Study ID Numbers: HMR
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors