Intima Media Thickness Regression in Dyslipidemic Teenagers

January 11, 2013 updated by: Laurent Legault, Université de Montréal

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneuve-Rosemont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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:
  • Lipitor
  • Statin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: 12 months
weight, height and BMI recorded before and after intervention
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: 6 months
Complete lipid profile were recorded at baseline , 6 months and 12 months after intervention.
6 months
lipid profile
Time Frame: 12 months
Lipid profile measured at end of study
12 months
BMI
Time Frame: 12 months
BMI neasured at baseline and at end of study
12 months
liver functions
Time Frame: 3 months
ALT/AST done at 3, 6, 9 and 12 months
3 months
liver functions
Time Frame: 6 months
ALT/AST done at 3, 6, 9, and 12 months
6 months
liver functions
Time Frame: 9 months
ALT/AST done at 3, 6, 9, and 12 months
9 months
liver functions
Time Frame: 12 months
ALT/AST done at 3, 6, 9, and 12 months
12 months
creatinine kinase
Time Frame: 3 months
CK done at 3 , 6, 9 and 12 months
3 months
creatinine kinase
Time Frame: 6 months
CK done at 3 , 6, 9 and 12 months
6 months
creatinine kinase
Time Frame: 9 months
CK done at 3 , 6, 9 and 12 months
9 months
creatinine kinase
Time Frame: 12 months
CK done at 3 , 6, 9 and 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Collaborators

Pfizer

Investigators

  • Principal Investigator: Laurent Legault, MD, Hopital Maisonneuve-Rosemont, UMontreal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (Estimate)

January 15, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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