Evaluation of High-Density Lipoprotein in Obesity Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

BMI 20-25 kg/m2

No interventions assigned to this group

2

BMI \> 30 kg/m2 with low TG (\<150) and normal HDL (\>50 for females, \>40 for males)

No interventions assigned to this group

3

BMI \> 30 kg/m2 with high TG (\>150) and low HDL (\<50 for females, \<40 for males)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No