Intima Media Thickness Regression in Dyslipidemic Teenagers
This study has been completed.
Sponsor:
Université de Montréal
Collaborator:
Pfizer
Information provided by (Responsible Party):
Laurent Legault, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01768481
First received: January 8, 2013
Last updated: January 11, 2013
Last verified: January 2013
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Purpose
Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Dyslipidemia |
Drug: Atorvastatin Drug: sugar pill |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque |
Resource links provided by NLM:
Further study details as provided by Université de Montréal:
Primary Outcome Measures:
- carotid intima media thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin)
Secondary Outcome Measures:
- weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]weight, height and BMI recorded before and after intervention
Other Outcome Measures:
- Lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]Complete lipid profile were recorded at baseline , 6 months and 12 months after intervention.
- lipid profile [ Time Frame: 12 months ] [ Designated as safety issue: No ]Lipid profile measured at end of study
- BMI [ Time Frame: 12 months ] [ Designated as safety issue: No ]BMI neasured at baseline and at end of study
- liver functions [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]ALT/AST done at 3, 6, 9 and 12 months
- liver functions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]ALT/AST done at 3, 6, 9, and 12 months
- liver functions [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]ALT/AST done at 3, 6, 9, and 12 months
- liver functions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]ALT/AST done at 3, 6, 9, and 12 months
- creatinine kinase [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]CK done at 3 , 6, 9 and 12 months
- creatinine kinase [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]CK done at 3 , 6, 9 and 12 months
- creatinine kinase [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]CK done at 3 , 6, 9 and 12 months
- creatinine kinase [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]CK done at 3 , 6, 9 and 12 months
| Enrollment: | 16 |
| Study Start Date: | January 2004 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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 Name: placebo
|
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.
Eligibility| Ages Eligible for Study: | 14 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768481
Locations
| Canada, Quebec | |
| Hôpital Maisonneuve-Rosemont | |
| Montréal, Quebec, Canada, H1T 2M4 | |
Sponsors and Collaborators
Université de Montréal
Pfizer
Investigators
| Principal Investigator: | Laurent Legault, MD | Hopital Maisonneuve-Rosemont, UMontreal |
More Information
No publications provided
| Responsible Party: | Laurent Legault, associate professor, Université de Montréal |
| ClinicalTrials.gov Identifier: | NCT01768481 History of Changes |
| Other Study ID Numbers: | HMR |
| Study First Received: | January 8, 2013 |
| Last Updated: | January 11, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Université de Montréal:
|
Obesity Dyslipidemia Cholesterol Intima media thickness |
Additional relevant MeSH terms:
|
Obesity Dyslipidemias Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Lipid Metabolism Disorders Metabolic Diseases Atorvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013