Dyslipidemia of Obesity Intervention in Teens (DO IT!)

Carelon Research

Status and phase

Completed

Phase 3

Conditions

Obesity

Dyslipidemia

Treatments

Drug: Pitavastatin

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02956590

PHN DO IT!

Details and patient eligibility

About

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.

Full 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.

Enrollment

122 patients

Sex

All

Ages

10 to 19 years old

Volunteers

No Healthy Volunteers

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