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Evaluation of High-Density Lipoprotein in Obesity Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00912236
Recruitment Status : Terminated (Investigator left institution)
First Posted : June 3, 2009
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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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

Condition or disease
Obesity

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.
Study Design
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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of High-Density Lipoprotein in Obesity Study
Actual Study Start Date : June 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : March 2012
Groups and Cohorts
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Group/Cohort
1
BMI 20-25 kg/m2
2
BMI > 30 kg/m2 with low TG (<150) and normal HDL (>50 for females, >40 for males)
3
BMI > 30 kg/m2 with high TG (>150) and low HDL (<50 for females, <40 for males)


Outcome Measures
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Primary Outcome Measures :
  1. To determine whether the functional activity of HDL is impaired in the setting of obesity [ Time Frame: Within 2 weeks of enrollment ]

Secondary Outcome Measures :
  1. To determine whether HDL is more susceptible to oxidative modification ex-vivo in obese patients by mass spectrometry [ Time Frame: Within 2 weeks of enrollment ]

Biospecimen Retention:   Samples Without DNA
Plasma and serum will be collected

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from Cleveland Clinic outpatient departments
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912236


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Stephen Nicholls, MBBS, PhD The Cleveland Clinic
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00912236    
Other Study ID Numbers: 09-302
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Cleveland Clinic:
Obesity
HDL
HDL functionality
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight