Evaluation of High-Density Lipoprotein in Obesity Study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00912236

Enrollment

Registered

2009-06-03

Start date

2009-06-30

Completion date

2012-03-31

Last updated

2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, HDL, HDL functionality

Brief summary

Obesity is associated with an impaired functioning HDL (good cholesterol) resulting in an acceleration in the development of atherosclerosis. This study will evaluate HDL functionality in patients with BMI (Body Mass Index) 20 - 25 and BMI \>30

Detailed description

This study will determine if the protective function of high-density lipoprotein (HDL) is impaired in obese patients and will help to enhance cardiovascular risk prediction. Carotid intima-media thickness (cIMT) will be captured as a means of assessing early vascular changes associated with low HDL levels in obesity. A novel measurement for clinical correlation has also been introduced called carotid extra-medial thickness (cEMT) which will be compared to cIMT in this obese population.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Group 1: * Age 20-80 * English speaking * BMI 20-25 kg/m2 * Group 2: * Age 20-80 * English speaking * BMI \> 30 kg/m2 * TG \> 150 and * HDL \> 50 (females) \>40 (Males) * Group 3: * Age 20-80 * English speaking * BMI \> 30 kg/m2 * TG \> 150 and * HDL \< 50 (females) \< 40 (males)

Exclusion criteria

* Self-reported history of: * Diabetes mellitus * Any previous lipid therapy within the last three months * Macrovascular events including TIA, stroke, myocardial infarction, heart failure, claudication, or known peripheral vascular disease * Current pregnancy

Design outcomes

Primary

Measure	Time frame
To determine whether the functional activity of HDL is impaired in the setting of obesity	Within 2 weeks of enrollment

Secondary

Measure	Time frame
To determine whether HDL is more susceptible to oxidative modification ex-vivo in obese patients by mass spectrometry	Within 2 weeks of enrollment

Countries

United States

Outcome results