Intima Media Thickness Regression in Dyslipidemic Teenagers

Université de Montréal

Status and phase: Completed; Phase 3

Conditions: Obesity; Dyslipidemia

Treatments: Drug: Atorvastatin; Drug: sugar pill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01768481

HMR

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obesity
• Abnormal Triglyceride levels (>1.7mmol/L).
• Abnormal HDL-C levels (1.0mmol/L)

Exclusion criteria

• Abnormal thyroid unfction (not treated)
• Diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

16 participants in 2 patient groups, including a placebo group

Statin

Experimental group

Description:

Atorvastatin 10 mg every day for one year

Treatment:

Drug: Atorvastatin

Sugar pill

Placebo Comparator group

Description:

Same size, taste and size placebo tablet (manufactured by sponsor) given every day for one year.

Treatment:

Drug: sugar pill