Clinical trial NCT01988454: Characterization of Dyslipidemia in Adolescent Obesity
Official title: Characterization of Dyslipidemia in Adolescent Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Health Diagnostic Laboratory, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of biomarker profiles
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: The Center for Nutrition and Preventive Medicine
state: North Carolina
Study officials:
name: Matthew D Acampora, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.