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Dyslipidemia of Obesity Intervention in Teens (DO IT!)

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ClinicalTrials.gov Identifier: NCT02956590
Recruitment Status : Active, not recruiting
First Posted : November 6, 2016
Last Update Posted : April 22, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
HealthCore-NERI

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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Obesity Drug: Pitavastatin Drug: Placebo Phase 3

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 TG/HDL-C ratio or low HDL-C). Enrollment will take place over 36 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dyslipidemia of Obesity Intervention in Teens Trial
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pitavastatin
Study Drug
Drug: Pitavastatin
Statin
Other Name: Livalo

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity (CDO) [ Time Frame: 2 years ]
    Pulse wave velocity (PWV)


Secondary Outcome Measures :
  1. the effect of pitavastatin versus placebo on vascular measures in obese adolescents with combined dyslipidemia of obesity (CDO) [ Time Frame: 2 years ]
    carotid intima media thickness (CIMT)

  2. the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity [ Time Frame: 2 years ]
    carotid artery stiffness

  3. the effect of pitavastatin versus placebo on Standard Fasting Lipid Profile (FLP) [ Time Frame: 2 years ]
    Change in time in standard fasting lipid profile

  4. the effect of pitavastatin versus placebo on lipid measures [ Time Frame: 2 years ]
    Change in time in apolipoproteins

  5. the effect of pitavastatin versus placebo on Nuclear magnetic resonance (NMR) Spectroscopy Lipoprotein Particle Assessment [ Time Frame: 2 years ]
    Change in time in NMR Spectroscopy Lipoprotein Particle Assessment

  6. the effect of pitavastatin versus placebo on composite outcome of Number of Participants With Abnormal Laboratory Values and/or Adverse Events [ Time Frame: 2 years ]
    Number of abnormal (yes/no) lab values based on Liver function tests (ALT, AST); creatine kinase (CK), muscle symptoms; markers of glycemic control/development of diabetes (fasting plasma glucose, HgbA1c) and change in surrogate markers of insulin sensitivity (fasting insulin, C-peptide, Homeostatic model assessment Insulin resistance (HOMA-IR), 1/insulin, QUICKI); height velocity (change in height z score) and adverse events

  7. the effect of pitavastatin versus placebo on prevalence of adverse events. [ Time Frame: 2 years ]
    Number of adverse events and other subject-reported symptoms (including neurocognitive and depressive symptoms).

  8. the effect of pitavastatin versus placebo on prevalence of abnormal Liver function tests (ALT, AST) [ Time Frame: 2 years ]
    Number of abnormal (yes/no) lab values based on Liver function tests (ALT, AST)

  9. the effect of pitavastatin versus placebo on prevalence of abnormal creatinine kinase (CK) tests [ Time Frame: 2 years ]
    Number of abnormal (yes/no) lab values based on creatinine kinase (CK) tests

  10. the effect of pitavastatin versus placebo on composite outcome of markers of glycemic control/development of diabetes [ Time Frame: 2 years ]
    Number of abnormal (yes/no) lab values based on markers of glycemic control/development of diabetes (fasting plasma glucose, HgbA1c)

  11. the effect of pitavastatin versus placebo on composite outcome of abnormal change in surrogate markers of insulin sensitivity [ Time Frame: 2 years ]
    Number of abnormal (yes/no) lab values based on change in surrogate markers of insulin sensitivity (fasting insulin, C-peptide, HOMA-IR)

  12. the effect of pitavastatin versus placebo on prevalence of abnormal changes in height [ Time Frame: 2 years ]
    Number of abnormal (yes/no) values based on change in height in time



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    • LDL-C <160 mg/dL and ≥90 mg/dL, and
    • TG <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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956590


Locations
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United States, Delaware
Nemours/Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Health System
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Indiana
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Hospital, University of Utah
Salt Lake City, Utah, United States, 84108
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5g 1X8
Sponsors and Collaborators
HealthCore-NERI
National Heart, Lung, and Blood Institute (NHLBI)
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Responsible Party: HealthCore-NERI
ClinicalTrials.gov Identifier: NCT02956590    
Other Study ID Numbers: PHN DO IT!
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthCore-NERI:
dyslipidemia
obesity
pitavastatin
lipids
Additional relevant MeSH terms:
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Obesity
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Lipid Metabolism Disorders
Metabolic Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents