ObesityNCT01988454
Characterization of Dyslipidemia in Adolescent Obesity
An observational study of Obesity, run by Health Diagnostic Laboratory, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Age 13-19
- BMI ≥25 (obese) or <25 (normal weight)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, 28277
About this study
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.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of biomarker profiles
To characterize and compare lipoprotein, inflammation and metabolic markers in obese and normal weight adolescents.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startSep 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Diagnostic Laboratory, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew D Acampora, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988454
- Sponsor's protocol ID
- R2011-2103
- Status last verified
- Feb 2015
- First submitted
- 7 Nov 2013
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20071470Berenson 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.
PubMed 9614255Must 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.
PubMed 1406836Raitakari 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.
PubMed 16385760Superko 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.
PubMed 19414656Haney 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.
PubMed 17606543Kang 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.
PubMed 12119567Miyashita 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.
PubMed 16278685Kelishadi 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.
PubMed 19013572
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Dyslipidemia in Adolescent Obesity
- ClinicalTrials.gov ID
- NCT01988454
- Acronym / sponsor ID
- R2011-2103
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Health Diagnostic Laboratory, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Age 13-19
- BMI ≥25 (obese) or <25 (normal weight)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of biomarker profiles
Time frame: Baseline
To characterize and compare lipoprotein, inflammation and metabolic markers in obese and normal weight adolescents.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
- Background: PubMed 20071470Ogden 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.
- Background: PubMed 9614255Berenson 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.
- Background: PubMed 1406836Must 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.
- Background: PubMed 16385760Raitakari 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.
- Background: PubMed 19414656Superko 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.
- Background: PubMed 17606543Haney 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.
- Background: PubMed 12119567Kang 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.
- Background: PubMed 16278685Miyashita 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.
- Background: PubMed 19013572Kelishadi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew D Acampora, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Health Diagnostic Laboratory, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of biomarker profiles (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988454, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.