Clinical trial NCT02956590: Dyslipidemia of Obesity Intervention in Teens
Official title: Dyslipidemia of Obesity Intervention in Teens Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Obesity
Keywords: dyslipidemia
obesity
pitavastatin
lipids
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-11-06
Enrollment: 122
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial of pitavastatin will determine efficacy and safety in this high risk population and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.

Detailed description: Randomized, double-blind, placebo-controlled clinical trial of pitavastatin for 2 years comparing the effect of study drug versus placebo on vascular measures in at least 354 adolescents with excess adiposity and CDO (defined as high non-HDL-C + high triglycerides (TG)/HDL-C ratio or low HDL-C). Enrollment will take place over 36 months.

Eligibility criteria: Inclusion Criteria:

* Boys and girls aged 10 to 19 years (with 2-year availability for study participation)
* BMI ≥85th percentile (using Centers for Disease Control (CDC) BMI charts)
* Fasting lipid profile x2 each with all of the following:

  * LDL-C \<160 mg/dL and ≥90 mg/dL, and
  * TG (triglycerides) \<500 mg/dL, and
  * TG/HDL-C ratio ≥2.5 or HDL-C \<45 mg/dL for boys or HDL-C \<50 mg/dL for girls, and
  * non-HDL-C ≥120 mg/dL
* Participant consent, or parental/guardian consent and participant assent

Exclusion Criteria:

* Current use of lipid lowering medication, growth hormone, systemic corticosteroids, cyclosporine, protease inhibitors, erythromycin, rifampin, colchicine, warfarin, second generation psychotropic drugs, oral isotretinoin; stable doses of stimulant or antidepressant therapy and antihypertensive medications will be accepted
* Known allergy or hypersensitivity to statin
* Patients who have had bariatric surgery or plan to have bariatric surgery during the trial
* Female who is pregnant, plans to become pregnant or is sexually active without contraception
* Uncontrolled stage 2 hypertension (systolic or diastolic blood pressure ≥95th percentile for age, sex and height percentile + 12 mmHg or ≥140/90, whichever is lower for participants \<13 years of age; ≥140/90 for participants ≥13 years of age) confirmed after an appropriate evaluation
* Diabetes (type 1 or type 2) by American Diabetes Association criteria (fasting glucose ≥126 mg/dL, HbA1c ≥6.5%, random glucose ≥200 mg/dL, or 2-hour oral glucose tolerance testing glucose ≥200 mg/dL)
* Use of insulin sensitizing therapy
* Known renal insufficiency (known chronic renal disease, estimated glomerular filtration rate (GFR) \<60 mL/min/1.73m2 at screening)
* Uncontrolled thyroid disease (TSH at screening \>1.5x upper limit of normal, clinical or other laboratory evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for 6 weeks prior to screening)
* Proteinuria suggestive of renal disease (more than trace together with an elevated urine protein:creatinine ratio as per local lab)
* Syndromic patients or patients with neurocognitive delay precluding adherence with study drug
* Liver disease other than non-alcoholic fatty liver disease (NAFLD) either diagnosed or suggested by alanine aminotransferase (ALT) ≥ 40 U/L, or severe NAFLD indicated by ALT ≥ 200 U/L
* Unexplained persistent elevated creatine kinase (CK) level \>3x upper limit of normal
* Plans to leave the geographic area before completion of the anticipated 2 years of trial participation
* Any unstable medical or emotional condition or chronic disease that would preclude following the protocol or impact valid vascular measurement
* Admits to current smoking, current alcohol consumption

Primary outcomes:
measure: the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity (CDO)
timeFrame: 2 years
Secondary outcomes:
measure: the effect of pitavastatin versus placebo on vascular measures in obese adolescents with combined dyslipidemia of obesity (CDO)
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on Standard Fasting Lipid Profile (FLP)
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on lipid measures
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on Nuclear magnetic resonance (NMR) Spectroscopy Lipoprotein Particle Assessment
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on composite outcome of Number of Participants With Abnormal Laboratory Values and/or Adverse Events
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on prevalence of adverse events.
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on prevalence of abnormal Liver function tests (ALT, AST)
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on prevalence of abnormal creatinine kinase (CK) tests
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on composite outcome of markers of glycemic control/development of diabetes
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on composite outcome of abnormal change in surrogate markers of insulin sensitivity
timeFrame: 2 years
measure: the effect of pitavastatin versus placebo on prevalence of abnormal changes in height
timeFrame: 2 years
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours/Alfred I duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital, University of Utah
state: Utah
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: