Intima Media Thickness Regression in Dyslipidemic Teenagers

Université de Montréal16 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obesity Dyslipidemia

Interventions

AtorvastatinDRUG

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

sugar pillDRUG

placebo controlled arm receives similarly looking placebo.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Obesity * Abnormal Triglyceride levels (\>1.7mmol/L). * Abnormal HDL-C levels (1.0mmol/L) Exclusion Criteria: * Abnormal thyroid unfction (not treated) * Diabetes

Locations (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

carotid intima media thickness

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

Time frame: 12 months

Secondary Outcomes

weight

weight, height and BMI recorded before and after intervention

Time frame: 12 months

Data from ClinicalTrials.gov

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