Intima Media Thickness Regression in Dyslipidemic Teenagers

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768481
• Other study ID #: HMR
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2013
• Last updated: January 11, 2013
• Start date: January 2004
• Est. completion date: June 2010

Study information

• Verified date: January 2013
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Obesity

Intervention

Drug:
• Atorvastatin
10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year
• sugar pill
placebo controlled arm receives similarly looking placebo.

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Montréal	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lipid profile	Complete lipid profile were recorded at baseline , 6 months and 12 months after intervention.	6 months	No
Other	lipid profile	Lipid profile measured at end of study	12 months	No
Other	BMI	BMI neasured at baseline and at end of study	12 months	No
Other	liver functions	ALT/AST done at 3, 6, 9 and 12 months	3 months	Yes
Other	liver functions	ALT/AST done at 3, 6, 9, and 12 months	6 months	Yes
Other	liver functions	ALT/AST done at 3, 6, 9, and 12 months	9 months	Yes
Other	liver functions	ALT/AST done at 3, 6, 9, and 12 months	12 months	Yes
Other	creatinine kinase	CK done at 3 , 6, 9 and 12 months	3 months	Yes
Other	creatinine kinase	CK done at 3 , 6, 9 and 12 months	6 months	Yes
Other	creatinine kinase	CK done at 3 , 6, 9 and 12 months	9 months	Yes
Other	creatinine kinase	CK done at 3 , 6, 9 and 12 months	12 months	Yes
Primary	carotid intima media thickness	Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin)	12 months	No
Secondary	weight	weight, height and BMI recorded before and after intervention	12 months	No