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Completed

NCT Number: NCT01768481

Intima Media Thickness Regression in Dyslipidemic Teenagers

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

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Key information

Conditions

Obesity Body Weight Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Abnormal thyroid unfction (not treated)
  • Diabetes

Treatment and study plan

atorvastatin

Drug

10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year

Other names: Statin, Lipitor

Sugar pill

Drug

placebo controlled arm receives similarly looking placebo.

Other names: placebo

Primary outcomes

  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 outcomes

  1. weight

    Time frame: 12 months

    weight, height and BMI recorded before and after intervention

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2010
First posted
Jan 15, 2013
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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