Dyslipidemia, Obesity
Conditions
Keywords
Obesity, Dyslipidemia, Cholesterol, Intima media thickness
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.
Interventions
DRUGAtorvastatin
10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year
DRUGsugar pill
placebo controlled arm receives similarly looking placebo.
Sponsors
Pfizer
Université de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Obesity * Abnormal Triglyceride levels (\>1.7mmol/L). * Abnormal HDL-C levels (1.0mmol/L)
Exclusion criteria
* Abnormal thyroid unfction (not treated) * Diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| carotid intima media thickness | 12 months | Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| weight | 12 months | weight, height and BMI recorded before and after intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| BMI | 12 months | BMI neasured at baseline and at end of study |
| Lipid profile | 6 months | Complete lipid profile were recorded at baseline , 6 months and 12 months after intervention. |
| creatinine kinase | 3 months | CK done at 3 , 6, 9 and 12 months |
| liver functions | 3 months | ALT/AST done at 3, 6, 9 and 12 months |
| lipid profile | 12 months | Lipid profile measured at end of study |
Countries
Canada
Outcome results
None listed