NCT01988454

Brief Summary

The primary objective of this pilot study is to characterize the profile of lipoprotein, inflammatory, and metabolic markers of cardiovascular disease in obese adolescents as compared to normal-weight age-matched controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

November 7, 2013

Last Update Submit

February 12, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Comparison of biomarker profiles

    To characterize and compare lipoprotein, inflammation and metabolic markers in obese and normal weight adolescents.

    Baseline

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Enrollment will be representative of the ethnic population of Charlotte, NC, estimated as 50% Caucasian, 35% African American, 10% Hispanic, and 5 % other.

You may qualify if:

  • Age 13-19
  • BMI ≥25 (obese) or \<25 (normal weight)

You may not qualify if:

  • Prior diagnosis of any eating disorder (e.g. anorexia or bulimia)
  • Prior diagnosis of any congenital lipid disorder (e.g. familial hypercholesterolemia)
  • Current use (or within past 6 months) of any lipid altering medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Nutrition and Preventive Medicine

Charlotte, North Carolina, 28277, United States

Location

Related Publications (9)

  • Ogden CL, Carroll MD, Curtin LR, Lamb MM, Flegal KM. Prevalence of high body mass index in US children and adolescents, 2007-2008. JAMA. 2010 Jan 20;303(3):242-9. doi: 10.1001/jama.2009.2012. Epub 2010 Jan 13.

    PMID: 20071470BACKGROUND

  • Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.

    PMID: 9614255BACKGROUND

  • Must A, Jacques PF, Dallal GE, Bajema CJ, Dietz WH. Long-term morbidity and mortality of overweight adolescents. A follow-up of the Harvard Growth Study of 1922 to 1935. N Engl J Med. 1992 Nov 5;327(19):1350-5. doi: 10.1056/NEJM199211053271904.

    PMID: 1406836BACKGROUND

  • Raitakari OT, Juonala M, Viikari JS. Obesity in childhood and vascular changes in adulthood: insights into the Cardiovascular Risk in Young Finns Study. Int J Obes (Lond). 2005 Sep;29 Suppl 2:S101-4. doi: 10.1038/sj.ijo.0803085.

    PMID: 16385760BACKGROUND

  • Superko HR. Advanced lipoprotein testing and subfractionation are clinically useful. Circulation. 2009 May 5;119(17):2383-95. doi: 10.1161/CIRCULATIONAHA.108.809582. No abstract available.

    PMID: 19414656BACKGROUND

  • Haney EM, Huffman LH, Bougatsos C, Freeman M, Steiner RD, Nelson HD. Screening and treatment for lipid disorders in children and adolescents: systematic evidence review for the US Preventive Services Task Force. Pediatrics. 2007 Jul;120(1):e189-214. doi: 10.1542/peds.2006-1801.

    PMID: 17606543BACKGROUND

  • Kang HS, Gutin B, Barbeau P, Litaker MS, Allison J, Le NA. Low-density lipoprotein particle size, central obesity, cardiovascular fitness, and insulin resistance syndrome markers in obese youths. Int J Obes Relat Metab Disord. 2002 Aug;26(8):1030-5. doi: 10.1038/sj.ijo.0802045.

    PMID: 12119567BACKGROUND

  • Miyashita M, Okada T, Kuromori Y, Harada K. LDL particle size, fat distribution and insulin resistance in obese children. Eur J Clin Nutr. 2006 Mar;60(3):416-20. doi: 10.1038/sj.ejcn.1602333.

    PMID: 16278685BACKGROUND

  • Kelishadi R, Cook SR, Amra B, Adibi A. Factors associated with insulin resistance and non-alcoholic fatty liver disease among youths. Atherosclerosis. 2009 Jun;204(2):538-43. doi: 10.1016/j.atherosclerosis.2008.09.034. Epub 2008 Oct 9.

    PMID: 19013572BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood and serum

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew D Acampora, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 20, 2013

Study Start

September 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

US(1)