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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014