Clincosm LogoSign in Get a demo

Intima Media Thickness Regression in Dyslipidemic Teenagers

Sponsor
Université de Montréal (Other)
Overall Status
Completed
CT.gov ID
NCT01768481
Collaborator
Pfizer (Industry)
16
Enrollment
1
Location
2
Arms
77
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Jan 1, 2004
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

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 Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. carotid intima media thickness [12 months]

      Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin)

    Secondary Outcome Measures

    1. weight [12 months]

      weight, height and BMI recorded before and after intervention

    Other Outcome Measures

    1. Lipid profile [6 months]

      Complete lipid profile were recorded at baseline , 6 months and 12 months after intervention.

    2. lipid profile [12 months]

      Lipid profile measured at end of study

    3. BMI [12 months]

      BMI neasured at baseline and at end of study

    4. liver functions [3 months]

      ALT/AST done at 3, 6, 9 and 12 months

    5. liver functions [6 months]

      ALT/AST done at 3, 6, 9, and 12 months

    6. liver functions [9 months]

      ALT/AST done at 3, 6, 9, and 12 months

    7. liver functions [12 months]

      ALT/AST done at 3, 6, 9, and 12 months

    8. creatinine kinase [3 months]

      CK done at 3 , 6, 9 and 12 months

    9. creatinine kinase [6 months]

      CK done at 3 , 6, 9 and 12 months

    10. creatinine kinase [9 months]

      CK done at 3 , 6, 9 and 12 months

    11. creatinine kinase [12 months]

      CK done at 3 , 6, 9 and 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 18 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laurent Legault, associate professor, Université de Montréal
    ClinicalTrials.gov Identifier:
    NCT01768481
    Other Study ID Numbers:
    • HMR
    First Posted:
    Jan 15, 2013
    Last Update Posted:
    Jan 15, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Laurent Legault, associate professor, Université de Montréal
    Obesity
    Dyslipidemia
    Cholesterol
    Intima media thickness
    Additional relevant MeSH terms:
    Dyslipidemias
    Atorvastatin

    Study Results

    No Results Posted as of Jan 15, 2013