Dyslipidemia of Obesity Intervention in Teens

Obesity Clinical Trial

— DO IT!  

Official title:

Dyslipidemia of Obesity Intervention in Teens Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956590
• Other study ID #: PHN DO IT!
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2018
• Est. completion date: April 21, 2023

Study information

• Verified date: June 2023
• Source: HealthCore-NERI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: April 21, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Obesity

Intervention

Drug:
• Pitavastatin
Statin
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Texas Children's Hospital	Houston	Texas
United States	Riley Hospital for Children at IU Health	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Wisconsin	Madison	Wisconsin
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Primary Children's Hospital, University of Utah	Salt Lake City	Utah
United States	Children's National Health System	Washington	District of Columbia
United States	Nemours/Alfred I duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
HealthCore-NERI	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity (CDO)	Pulse wave velocity (PWV)	2 years
Secondary	the effect of pitavastatin versus placebo on vascular measures in obese adolescents with combined dyslipidemia of obesity (CDO)	carotid intima media thickness (CIMT)	2 years
Secondary	the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity	carotid artery stiffness	2 years
Secondary	the effect of pitavastatin versus placebo on Standard Fasting Lipid Profile (FLP)	Change in time in standard fasting lipid profile	2 years
Secondary	the effect of pitavastatin versus placebo on lipid measures	Change in time in apolipoproteins	2 years
Secondary	the effect of pitavastatin versus placebo on Nuclear magnetic resonance (NMR) Spectroscopy Lipoprotein Particle Assessment	Change in time in NMR Spectroscopy Lipoprotein Particle Assessment	2 years
Secondary	the effect of pitavastatin versus placebo on composite outcome of Number of Participants With Abnormal Laboratory Values and/or Adverse Events	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	2 years
Secondary	the effect of pitavastatin versus placebo on prevalence of adverse events.	Number of adverse events and other subject-reported symptoms (including neurocognitive and depressive symptoms).	2 years
Secondary	the effect of pitavastatin versus placebo on prevalence of abnormal Liver function tests (ALT, AST)	Number of abnormal (yes/no) lab values based on Liver function tests (ALT, AST)	2 years
Secondary	the effect of pitavastatin versus placebo on prevalence of abnormal creatinine kinase (CK) tests	Number of abnormal (yes/no) lab values based on creatinine kinase (CK) tests	2 years
Secondary	the effect of pitavastatin versus placebo on composite outcome of markers of glycemic control/development of diabetes	Number of abnormal (yes/no) lab values based on markers of glycemic control/development of diabetes (fasting plasma glucose, HgbA1c)	2 years
Secondary	the effect of pitavastatin versus placebo on composite outcome of abnormal change in surrogate markers of insulin sensitivity	Number of abnormal (yes/no) lab values based on change in surrogate markers of insulin sensitivity (fasting insulin, C-peptide, HOMA-IR)	2 years
Secondary	the effect of pitavastatin versus placebo on prevalence of abnormal changes in height	Number of abnormal (yes/no) values based on change in height in time	2 years