Characterization of Dyslipidemia in Adolescent Obesity

February 12, 2015 updated by: Health Diagnostic Laboratory, Inc.
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • The Center for Nutrition and Preventive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of biomarker profiles
Time Frame: Baseline
To characterize and compare lipoprotein, inflammation and metabolic markers in obese and normal weight adolescents.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Diagnostic Laboratory, Inc.

Investigators

  • Principal Investigator: Matthew D Acampora, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2011-2103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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