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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

Tracking Information
First Submitted Date  ICMJE October 21, 2016
First Posted Date  ICMJE November 7, 2016
Last Update Posted Date September 13, 2019
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02956590 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
  • 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)
  • 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
  • the effect of pitavastatin versus placebo on Standard Fasting Lipid Profile (FLP) [ Time Frame: 2 years ]
    Change in time in standard fasting lipid profile
  • the effect of pitavastatin versus placebo on lipid measures [ Time Frame: 2 years ]
    Change in time in apolipoproteins
  • 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
  • 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
  • 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).
  • 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)
  • 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
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • 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)
  • 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
  • the effect of pitavastatin versus placebo on Standard Fasting Lipid Profile (FLP) [ Time Frame: 2 years ]
    Change in time in each of the following lipid measures: standard fasting lipid profile and apolipoproteins
  • the effect of pitavastatin versus placebo on NMR Spectroscopy Lipoprotein Particle Assessment [ Time Frame: 2 years ]
    Change in time in NMR Spectroscopy Lipoprotein Particle Assessment
  • the effect of pitavastatin versus placebo on prevalence of abnormal lab values [ Time Frame: 2 years ]
    Prevalence 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, HOMA-IR, 1/insulin, QUICKI); height velocity (change in height z score
  • the effect of pitavastatin versus placebo on prevalence of adverse events. [ Time Frame: 2 years ]
    Prevalence of adverse events and other subject-reported symptoms (including neurocognitive and depressive symptoms).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dyslipidemia of Obesity Intervention in Teens
Official Title  ICMJE Dyslipidemia of Obesity Intervention in Teens Trial
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dyslipidemia
  • Obesity
Intervention  ICMJE
  • Drug: Pitavastatin
    Statin
    Other Name: Livalo
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Pitavastatin
    Study Drug
    Intervention: Drug: Pitavastatin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
354
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julie Miller 617-972-3197 jmiller@neriscience.com
Contact: Kerri Hayes khayes@neriscience.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02956590
Other Study ID Numbers  ICMJE PHN DO-IT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New England Research Institutes
Study Sponsor  ICMJE New England Research Institutes
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE Not Provided
PRS Account New England Research Institutes
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP