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Dyslipidemia of Obesity Intervention in Teens (DO-IT)

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ClinicalTrials.gov Identifier: NCT02956590
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 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



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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


Contacts
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Contact: Julie Miller 617-972-3197 jmiller@neriscience.com
Contact: Kerri Hayes khayes@neriscience.com

Locations
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United States, Delaware
Nemours/Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Samuel Gidding, MD       sgidding@nemours.org   
Principal Investigator: Samuel Gidding, MD         
United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
Contact: Michele Mietus-Snyder, MD       mmsynder@childrensnational.org   
Principal Investigator: Michele Mietus-Snyder, MD         
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Miriam Voss, MD, MSPH       mvos@emory.edu   
Principal Investigator: Miriam Vos, MD, MSPH         
United States, Indiana
Riley Hospital for Children at IU Health Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jacqueline Maiers, MD       jmaiers@iu.edu   
Principal Investigator: Jacqueline Maiers, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sarah de Ferranti, MD, MPH       sarah.deferranti@cardio.chboston.org   
Principal Investigator: Sarah de Ferranti, MD, MPH         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Caren Goldberg, MD, MS       cgoldberg@umich.edu   
Principal Investigator: Caren Goldberg, MD, MS         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Nicolas Madsen, MD, MPH       nicolas.madsen@cchmc.org   
Principal Investigator: Nicolas Madsen, MD, MPH         
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Julie Brothers, MD, FAAP       brothersj@email.chop.edu   
Principal Investigator: Julie Brothers, MD, FAAp         
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Silva Arslanian, MD       silva.arslanian@chp.edu   
Principal Investigator: Silva Arslanian, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Andrew Atz, MD       atzam@musc.edu   
Principal Investigator: Andrew Atz, MD         
United States, Texas
Texas Children's Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: S. Kristen Sexson, MD, Phd       sxsexson@texaschildrens.org   
Principal Investigator: S. Kristen Sexson, MD, Phd         
United States, Utah
Primary Children's Hospital, University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Adam Ware, MD       adam.ware@hsc.utah.edu   
Principal Investigator: Adam Ware, MD         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5g 1X8
Contact: Brian McCrindle, MD, MPH       brian.mccrindle@sickkids.ca   
Principal Investigator: Brian McCrindle, MD, MPH         
Sponsors and Collaborators
New England Research Institutes
National Heart, Lung, and Blood Institute (NHLBI)

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Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT02956590     History of Changes
Other Study ID Numbers: PHN DO-IT
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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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 New England Research Institutes:
dyslipidemia
obesity
pitavastatin
lipids
Additional relevant MeSH terms:
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Obesity
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
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