Intima Media Thickness Regression in Dyslipidemic Teenagers

U

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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