Characterization of Dyslipidemia in Adolescent Obesity

NCT ID: NCT01988454

Last Updated: 2015-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Diagnostic Laboratory, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew D Acampora, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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The Center for Nutrition and Preventive Medicine

Charlotte, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20071470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9614255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1406836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16385760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19414656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17606543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12119567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16278685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19013572 (View on PubMed)

Other Identifiers

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R2011-2103

Identifier Type: -

Identifier Source: org_study_id

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