Characterization of Dyslipidemia in Adolescent Obesity

Obesity Clinical Trial

Official title:

Characterization of Dyslipidemia in Adolescent Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988454
• Other study ID #: R2011-2103
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: February 12, 2015
• Start date: September 2011
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Health Diagnostic Laboratory, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dyslipidemias
• Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
United States	The Center for Nutrition and Preventive Medicine	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Health Diagnostic Laboratory, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. Review. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Superko HR. Advanced lipoprotein testing and subfractionation are clinically useful. Circulation. 2009 May 5;119(17):2383-95. doi: 10.1161/CIRCULATIONAHA.108.809582. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of biomarker profiles	To characterize and compare lipoprotein, inflammation and metabolic markers in obese and normal weight adolescents.	Baseline	No