Dyslipidemia of Obesity Intervention in Teens

Conditions:High Cholesterol, Obesity Weight Loss
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Age Range:10 - 17
Start Date:May 1, 2018
End Date:May 31, 2022
Contact:Julie Miller

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Dyslipidemia of Obesity Intervention in Teens Trial

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

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 obese
(body mass index >95th percentile) adolescents with CDO (defined as high non-HDL-C + high
TG/HDL-C ratio or low HDL-C). Enrollment will take place over 18 months.

Inclusion Criteria:

- Boys and girls aged 10 to 17 years (with 2 year availability for study participation)

- BMI >95th percentile (using CDC BMI charts)

- Fasting lipid profile x2 each with all of the following:

- LDL-C <160 mg/dL, and

- TG <500 mg/dL, and

- TG/HDL-C ratio > 3.0 or HDL-C <45 mg/dL for boys or HDL-C <50 mg/dL for girls,

- non-HDL-C >145 mg/dL

- Participant consent, or parental/guardian consent and participant assent

- Participant fluency in English

Exclusion Criteria:

- Current use of lipid lowering medication, antihypertensive medication, growth hormone,
systemic corticosteroids, cyclosporine, protease inhibitors, colchicine, warfarin,
second generation psychotropic drugs, oral isotretinoin; stable doses of stimulant or
antidepressant therapy will be accepted

- Female who is pregnant, plans to become pregnant or is sexually active without

- Stage 2 hypertension (systolic or diastolic blood pressure above the 99th percentile
for age, sex and height percentile + 5 mmHg; confirmed after an appropriate

- Diabetes (type 1 or type 2) by American Diabetes Association criteria (fasting glucose
>126 mg/dL, random glucose >200 mg/dL, or 2-hour oral glucose tolerance testing
glucose >200 mg/dL)

- Prediabetes or polycystic ovary syndrome on insulin sensitizing therapy

- Known renal insufficiency

- Uncontrolled thyroid disease

- Proteinuria suggestive of renal disease (urine protein: creatinine >0.2)

- 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) ≥ 50 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
We found this trial at
1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Principal Investigator: Miriam Vos, MD, MSPH
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
Atlanta, GA
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Principal Investigator: Nicolas Madsen, MD, MPH
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
Cincinnati, OH
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South 34th Street
Philadelphia, Pennsylvania 19104
Principal Investigator: Julie Brothers, MD, FAAp
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
Philadelphia, PA
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Caren Goldberg, MD, MS
University of Michigan Health System The University of Michigan is home to one of the...
Ann Arbor, MI
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Sarah de Ferranti, MD, MPH
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
Boston, MA
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171 Ashley Avenue
Charleston, South Carolina 29425
Principal Investigator: Andrew Atz, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Charleston, SC
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: S. Kristen Sexson, MD, Phd
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
Houston, TX
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Indianapolis, Indiana 46202
Principal Investigator: Jacqueline Maiers, MD
Indianapolis, IN
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Silva Arslanian, MD
Pittsburgh, PA
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100 Mario Capecchi Drive
Salt Lake City, Utah 84113
Principal Investigator: Adam Ware, MD
Salt Lake City, UT
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555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Brian McCrindle, MD, MPH
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Washington, District of Columbia 20010
Principal Investigator: Michele Mietus-Snyder, MD
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Wilmington, Delaware 19803
Principal Investigator: Samuel Gidding, MD
Wilmington, DE
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