Back to resultsIntima Media Thickness Regression in Dyslipidemic Teenagers
Primary Purpose
Obesity, Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Atorvastatin
sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Dyslipidemia, Cholesterol, Intima media thickness
Eligibility 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
Sites / Locations
- Hôpital Maisonneuve-Rosemont
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Statin
Sugar pill
Arm Description
Atorvastatin 10 mg every day for one year
Same size, taste and size placebo tablet (manufactured by sponsor) given every day for one year.
Outcomes
Primary Outcome Measures
carotid intima media thickness
Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin)
Secondary Outcome Measures
weight
weight, height and BMI recorded before and after intervention
Full Information
NCT ID
NCT01768481
First Posted
January 8, 2013
Last Updated
January 11, 2013
Sponsor
Université de Montréal
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01768481
Brief Title
Intima Media Thickness Regression in Dyslipidemic Teenagers
Official Title
Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Dyslipidemia
Keywords
Obesity, Dyslipidemia, Cholesterol, Intima media thickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Statin
Arm Type
Experimental
Arm Description
Atorvastatin 10 mg every day for one year
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Same size, taste and size placebo tablet (manufactured by sponsor) given every day for one year.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Statin, Lipitor
Intervention Description
10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year
Intervention Type
Drug
Intervention Name(s)
sugar pill
Other Intervention Name(s)
placebo
Intervention Description
placebo controlled arm receives similarly looking placebo.
Primary Outcome Measure Information:
Title
carotid intima media thickness
Description
Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
weight
Description
weight, height and BMI recorded before and after intervention
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Lipid profile
Description
Complete lipid profile were recorded at baseline , 6 months and 12 months after intervention.
Time Frame
6 months
Title
lipid profile
Description
Lipid profile measured at end of study
Time Frame
12 months
Title
BMI
Description
BMI neasured at baseline and at end of study
Time Frame
12 months
Title
liver functions
Description
ALT/AST done at 3, 6, 9 and 12 months
Time Frame
3 months
Title
liver functions
Description
ALT/AST done at 3, 6, 9, and 12 months
Time Frame
6 months
Title
liver functions
Description
ALT/AST done at 3, 6, 9, and 12 months
Time Frame
9 months
Title
liver functions
Description
ALT/AST done at 3, 6, 9, and 12 months
Time Frame
12 months
Title
creatinine kinase
Description
CK done at 3 , 6, 9 and 12 months
Time Frame
3 months
Title
creatinine kinase
Description
CK done at 3 , 6, 9 and 12 months
Time Frame
6 months
Title
creatinine kinase
Description
CK done at 3 , 6, 9 and 12 months
Time Frame
9 months
Title
creatinine kinase
Description
CK done at 3 , 6, 9 and 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Legault, MD
Organizational Affiliation
Hopital Maisonneuve-Rosemont, UMontreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Intima Media Thickness Regression in Dyslipidemic Teenagers
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