Intima Media Thickness Regression in Dyslipidemic Teenagers

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Laurent Legault, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01768481
First received: January 8, 2013
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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


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

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
Official Title: Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • carotid intima media thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    weight, height and BMI recorded before and after intervention


Other Outcome Measures:
  • Lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Complete lipid profile were recorded at baseline , 6 months and 12 months after intervention.

  • lipid profile [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Lipid profile measured at end of study

  • BMI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    BMI neasured at baseline and at end of study

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

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

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

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

  • creatinine kinase [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    CK done at 3 , 6, 9 and 12 months

  • creatinine kinase [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    CK done at 3 , 6, 9 and 12 months

  • creatinine kinase [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    CK done at 3 , 6, 9 and 12 months

  • creatinine kinase [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Laurent Legault, associate professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01768481     History of Changes
Other Study ID Numbers: HMR
Study First Received: January 8, 2013
Last Updated: January 11, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Obesity
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014