Intima Media Thickness Regression in Dyslipidemic Teenagers

Phase 3

Completed

• Conditions: Obesity; Dyslipidemia
• Interventions: Drug: Atorvastatin; Drug: sugar pill

• Registration Number: NCT01768481
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2009-12
• Study Completion: 2010-06
• Status Verified: 2013-01
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-11
• Last Update Submitted: 2013-01-11
• Study First Posted: 2013-01-15
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

Exclusion Criteria

• Abnormal thyroid unfction (not treated)
• Diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin	Atorvastatin	Atorvastatin 10 mg every day for one year
Sugar pill	sugar pill	Same size, taste and size placebo tablet (manufactured by sponsor) given every day for one year.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
weight	12 months	weight, height and BMI recorded before and after intervention

Trial Locations

Locations (1)

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montréal, Quebec, Canada