Evaluation of High-Density Lipoprotein in Obesity Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo Hyun (Esther) Kim, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00912236
First received: May 20, 2009
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of High-Density Lipoprotein in Obesity Study

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • To determine whether the functional activity of HDL is impaired in the setting of obesity [ Time Frame: Within 2 weeks of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma and serum will be collected


Enrollment: 77
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912236

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Stephen Nicholls, MBBS, PhD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Soo Hyun (Esther) Kim, Co-Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00912236     History of Changes
Other Study ID Numbers: 09-302
Study First Received: May 20, 2009
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Obesity
HDL
HDL functionality

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 21, 2014